Methods for operating mode transitions and related infusion devices and systems

ABSTRACT

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method involves operating an infusion device to deliver fluid to a user in accordance with a first operating mode of a plurality of operating modes, obtaining operational information pertaining to the first operating mode, and obtaining clinical information pertaining to the user. A destination operating mode of the plurality of operating modes is determined based at least in part on the operational information and the clinical information, and the infusion device is operated to deliver the fluid in accordance with the destination operating mode in a manner that is influenced by at least a portion of the operational information pertaining to the first operating mode.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/561,133, filed Dec. 4, 2014.

TECHNICAL FIELD

Embodiments of the subject matter described herein relate generally tomedical devices, and more particularly, embodiments of the subjectmatter relate to managing transitions into fluid infusion deviceoperating modes.

BACKGROUND

Infusion pump devices and systems are relatively well known in themedical arts, for use in delivering or dispensing an agent, such asinsulin or another prescribed medication, to a patient. A typicalinfusion pump includes a pump drive system which typically includes asmall motor and drive train components that convert rotational motormotion to a translational displacement of a plunger (or stopper) in areservoir that delivers medication from the reservoir to the body of auser via a fluid path created between the reservoir and the body of auser. Use of infusion pump therapy has been increasing, especially fordelivering insulin for diabetics.

Continuous insulin infusion provides greater control of a diabetic'scondition, and hence, control schemes are being developed that allowinsulin infusion pumps to monitor and regulate a user's blood glucoselevel in a substantially continuous and autonomous manner. For example,an insulin infusion pump may operate in a closed-loop operating modeovernight while a user is sleeping to regulate the user's glucose levelto a target glucose level. In practice, multiple different operatingmodes for providing continuous insulin infusion may be supported by aninfusion pump. However, care must be taken when transitioning betweenoperating modes to avoid potentially compromising a user's condition andensure compliance with applicable regulatory requirements.

Additionally, in some situations, one or more preconditions must besatisfied before entering to a particular operating mode is allowed.When preconditions are not satisfied, entry into the operating mode maybe denied, which may frustrate a user who would like to operate theinfusion pump in that particular operating mode at that particularmoment in time. Additionally, after entering a particular operatingmode, various conditions may be encountered while operating the infusionpump in that operating mode that result in generation of alerts, whichcould be disruptive or distracting to the user. Thus, it is desirable toprovide multiple different operating modes that facilitate greater andmore customizable control over the user's physiological conditionwithout degrading the user experience.

BRIEF SUMMARY

Infusion devices, systems and related methods of operation in accordancewith various operating modes are provided. One exemplary method ofoperating an infusion device to deliver fluid to a user in accordancewith an operating mode involves obtaining operational informationpertaining to one or more prior instances of the operating mode,obtaining status information pertaining to the infusion device, anddetermining a diagnosis time based at least in part on the operationalinformation. The diagnosis time is prior to a subsequent instance of theoperating mode. At the diagnosis time, the method automaticallydetermines the viability of the subsequent instance of the operatingmode based at least in part on the status information and automaticallygenerates a notification indicative of a recommended action for the userbased at least in part on the viability.

In one embodiment, an infusion device is provided. The infusion deviceincludes a user interface, a data storage element to maintain statusinformation pertaining to the infusion device, a motor operable todeliver fluid influencing a physiological condition to a body of a user,and a control system. The control system is coupled to the motor, thedata storage element, and the user interface. The control systemoperates the motor in a first instance of an operating mode to deliverthe fluid in accordance with the operating mode, stores operationalinformation pertaining to the first instance of the operating mode inthe data storage element, and determines a diagnosis time based at leastin part on the operational information pertaining to the first instanceof the operating mode. At the diagnosis time, the control systemautomatically determines the viability of a subsequent instance of theoperating mode based at least in part on the status information andautomatically provides a notification indicative of a recommended actionvia the user interface based at least in part on the viability.

An embodiment of an infusion system is also provided. The infusionsystem includes a user interface, a sensing arrangement to obtainmeasurements of a physiological condition in a body of a user, and aninfusion device coupled to the user interface and the sensingarrangement. The infusion device delivers fluid influencing thephysiological condition to the body of the user based at least in parton the measurements in accordance with an operating mode. The infusiondevice maintains status information pertaining to operation of theinfusion device and operational information pertaining to one or moreprevious instances of the operating mode, and determines a diagnosistime in advance of an expected start time for a subsequent instance ofthe operating mode based at least in part on the operationalinformation. At the diagnosis time, the infusion device automaticallydetermines the viability of the subsequent instance of the operatingmode based at least in part on the status information and automaticallyprovides a notification indicative of a recommended action via the userinterface based at least in part on the viability.

In another embodiment, a method involves operating an infusion device todeliver fluid to a user in accordance with a first operating mode of aplurality of operating modes, obtaining operational informationpertaining to the first operating mode, and obtaining clinicalinformation pertaining to the user. The method continues by determininga destination operating mode of the plurality of operating modes basedat least in part on the operational information and the clinicalinformation, and operating the infusion device to deliver the fluid inaccordance with the destination operating mode in a manner that isinfluenced by at least a portion of the operational informationpertaining to the first operating mode.

Another embodiment of an infusion device includes a data storage elementto maintain operational information pertaining to a first operating modeof a plurality of operating modes and clinical information pertaining toa user, a motor operable to deliver fluid influencing a physiologicalcondition to a body of the user, and a control system coupled to themotor and the data storage element. The control system operates themotor to deliver the fluid in accordance with the first operating mode,determines a destination operating mode of the plurality of operatingmodes based at least in part on the operational information and theclinical information, and operates the infusion device to deliver thefluid in accordance with the destination operating mode in a manner thatis influenced by at least a portion of the operational informationpertaining to the first operating mode.

In yet another embodiment, a method of operating an infusion deviceoperable to deliver insulin to a user involves operating the infusiondevice to deliver the insulin in accordance with a first operating modeof a plurality of operating modes, obtaining operational informationpertaining to the first operating mode, and obtaining one or moreglucose values for the user. In response to an indication to terminatethe first operating mode, the method continues by determining a set ofone or more possible operating modes from the plurality of operatingmodes based at least in part on the one or more glucose values and theoperational information. The method selects a destination operating modefrom the set of one or more possible operating modes and operates theinfusion device to deliver the insulin in accordance with thedestination operating mode in a manner that is influenced by at least aportion of the operational information pertaining to the first operatingmode.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the subject matter may be derived byreferring to the detailed description and claims when considered inconjunction with the following figures, wherein like reference numbersrefer to similar elements throughout the figures, which may beillustrated for simplicity and clarity and are not necessarily drawn toscale.

FIG. 1 depicts an exemplary embodiment of an infusion system;

FIG. 2 depicts a plan view of an exemplary embodiment of a fluidinfusion device suitable for use in the infusion system of FIG. 1;

FIG. 3 is an exploded perspective view of the fluid infusion device ofFIG. 2;

FIG. 4 is a cross-sectional view of the fluid infusion device of FIGS.2-3 as viewed along line 4-4 in FIG. 3 when assembled with a reservoirinserted in the infusion device;

FIG. 5 is a block diagram of an exemplary control system suitable foruse in a fluid infusion device, such as the fluid infusion device ofFIG. 1 or FIG. 2;

FIG. 6 is a block diagram of an exemplary pump control system suitablefor use in the control system of FIG. 5;

FIG. 7 is a block diagram of a closed-loop control system that may beimplemented or otherwise supported by the pump control system in thefluid infusion device of FIG. 5 in one or more exemplary embodiments;

FIG. 8 is a flow diagram of an exemplary transition diagnosis processsuitable for use with the control system of FIG. 5;

FIG. 9 is a block diagram of an exemplary management system that may beimplemented or otherwise supported by the pump control system in thefluid infusion device of FIG. 5 in one or more exemplary embodiments;and

FIG. 10 is a flow diagram of an exemplary operating mode transitionprocess suitable for use with the control system of FIG. 5.

DETAILED DESCRIPTION

The following detailed description is merely illustrative in nature andis not intended to limit the embodiments of the subject matter or theapplication and uses of such embodiments. As used herein, the word“exemplary” means “serving as an example, instance, or illustration.”Any implementation described herein as exemplary is not necessarily tobe construed as preferred or advantageous over other implementations.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

While the subject matter described herein can be implemented in anyelectronic device that includes a motor, exemplary embodiments describedbelow are implemented in the form of medical devices, such as portableelectronic medical devices. Although many different applications arepossible, the following description focuses on a fluid infusion device(or infusion pump) as part of an infusion system deployment. For thesake of brevity, conventional techniques related to infusion systemoperation, insulin pump and/or infusion set operation, and otherfunctional aspects of the systems (and the individual operatingcomponents of the systems) may not be described in detail here. Examplesof infusion pumps may be of the type described in, but not limited to,U.S. Pat. Nos. 4,562,751; 4,685,903; 5,080,653; 5,505,709; 5,097,122;6,485,465; 6,554,798; 6,558,320; 6,558,351; 6,641,533; 6,659,980;6,752,787; 6,817,990; 6,932,584; and 7,621,893; each of which are hereinincorporated by reference.

Embodiments of the subject matter described herein generally relate tofluid infusion devices including a motor that is operable to linearlydisplace a plunger (or stopper) of a reservoir provided within the fluidinfusion device to deliver a dosage of fluid, such as insulin, to thebody of a user. Dosage commands that govern operation of the motor maybe generated in an automated manner in accordance with the deliverycontrol scheme associated with a particular operating mode. For example,in a closed-loop operating mode, the dosage commands are generated basedon a difference between a current (or most recent) measurement of aphysiological condition in the body of the user (e.g., an interstitialfluid glucose level) and a target (or reference) value for thatphysiological condition. In a predictive operating mode, the dosagecommands may be influenced by a predicted value (or anticipatedmeasurement) for that physiological condition in the body of the user atsome point in the future. Conversely, in an open-loop operating mode,the dosage commands may be configured to implement a predetermineddelivery rate substantially independent of the current or predictedmeasurements of the physiological condition of the user.

As described in greater detail below primarily in the context of FIG. 8,in one or more exemplary embodiments, one or more diagnostic checks areperformed prior to when an operating mode is entered to determinewhether or not the operating mode will be viable at the expected time ofentry. In this regard, various operating modes may require a particularamount of historical delivery data, measurement data, calibration data,or the like in order to calculate control parameters for implementingthe operating mode. Accordingly, the diagnostic checks verify orotherwise confirm the required information is available for calculatingthe control parameter for implementing a subsequent instance of theoperating mode. Additionally, the diagnostic checks may verify orotherwise confirm the operational status of various physical componentsof the infusion device to ensure those components are unlikely to be theroot cause of any user alerts generated when the operating mode isimplemented. For example, physical diagnostic checks may verify theremaining amount of battery life, the remaining amount of fluid in thereservoir, the amount of life remaining on the sensor(s), and the likeare sufficient to last throughout the anticipated duration of the nextinstance of the operating mode.

In exemplary embodiments, operational information (e.g., start time,duration, and the like) pertaining to one or more prior instances of theoperating mode is utilized to determine a time for when the diagnosticcheck(s) should be performed prior to an anticipated subsequent instanceof the operating mode. At that diagnosis time in advance of the expectedstart time, various physical and algorithmic diagnostic checks areautomatically performed to determine the viability of reinitiating orreentering the operating mode at that expected start time. Thediagnostic checks determine the viability based at least in part onstatus information pertaining to the current and/or previous operationof the infusion device. This status information may include clinicalstatus information or data for the patient (e.g., historical deliverydata, reference measurement data, sensor measurement data, sensorcalibration data, and the like) along with physical status informationfor the infusion device or other components of the infusion system(e.g., current battery level for the infusion device and/or sensor(s),current reservoir fluid level, and the like). When it is determined thata subsequent instance of the operating mode is not likely to be viableat the expected start time based on the currently available statusinformation, an alert or user notification is automatically generatedand provided to the user. The user notification indicates one or morerecommended remedial actions that may be undertaken by the user toimprove the future viability of the operating mode. In this manner, theuser may engage in remedial actions in advance of the expected starttime to increase the likelihood if not ensure that the operating modewill be viable by the time the user would like to reenter the operatingmode. Additionally, remedial actions may also increase the likelihood ifnot ensure that the operating mode can be implemented for an anticipatedduration without generating additional alerts that could otherwiserequire action by the user while in the operating mode. Thus, theoverall user experience is improved by increasing the likelihood thatthe operating mode will be available when the user would like to enterthe operating mode, while also decreasing the likelihood of the userbeing disturbed by additional alerts once the infusion device isimplementing that operating mode.

As described in greater detail below primarily in the context of FIGS.9-10, in exemplary embodiments, transitions between operating modesimplemented by the infusion device are also supervised or otherwisemanaged to maintain satisfactory control of the user's physiologicalcondition and ensure compliance with applicable delivery control rules.The delivery control rules may be dictated by regulatory requirements,manufacturer requirements, device settings, user preferences, or thelike. In this regard, the destination operating mode is initializedusing operational information pertaining to the current operation of theinfusion device in the initial operating mode being transitioned from toprovide a relatively seamless transition between operating modes. Inexemplary embodiments, before transitioning to the destination operatingmode, information pertaining to the operating mode currently beingimplemented is obtained. The operational information characterizes thecurrent instance of the current operating mode and may include, forexample, delivery or suspension information (e.g., whether or notdelivery was suspended at any time, the duration delivery was suspended,and the like), the values of any active timers (e.g., the duration of acurrent instance of delivery suspension, the duration of a currentrefractory period, and the like), alert information (e.g., whether ornot any alerts where generated, and information identifying what typesof alerts were generated or the root cause) and information indicatingwhy the current instance of the current operating mode is being exited.At least a portion of the operational information is provided to thedestination operating mode upon the transition from the previousoperating mode, with the operation of the infusion device in accordancewith the destination operating mode being influenced by that operationalinformation. For example, the destination operating mode may beinitialized with the same timer values or counter values from thepreceding operating mode to ensure that no time constraints or otherapplicable maximum limits are violated by the destination operatingmode.

In exemplary embodiments, before transitioning into a destinationoperating mode, clinical status information pertaining to thephysiological condition of the user is also obtained. As describedabove, the clinical information may include, for example, recent orhistorical sensor measurement values of the physiological condition ofthe user, reference measurement values of the physiological condition ofthe user, sensor calibration history for the user, and the like. In oneor more embodiments, the destination operating mode is automaticallydetermined based at least in part on portions of the clinicalinformation and the operational information for the current operatingmode along with the device settings or user preferences establishing ahierarchical order for the operating modes. In this regard, the clinicalinformation and/or the operational information may be used to identifyand exclude operating modes that are likely to violate any applicableconstraints or requirements upon entry, with the hierarchicalinformation for the operating modes being used to select the mostpreferable operating mode from among the remaining potential operatingmodes.

Turning now to FIG. 1, one exemplary embodiment of an infusion system100 includes, without limitation, a fluid infusion device (or infusionpump) 102, a sensing arrangement 104, a command control device (CCD)106, and a computer 108. The components of an infusion system 100 may berealized using different platforms, designs, and configurations, and theembodiment shown in FIG. 1 is not exhaustive or limiting. In practice,the infusion device 102 and the sensing arrangement 104 are secured atdesired locations on the body of a user (or patient), as illustrated inFIG. 1. In this regard, the locations at which the infusion device 102and the sensing arrangement 104 are secured to the body of the user inFIG. 1 are provided only as a representative, non-limiting, example. Theelements of the infusion system 100 may be similar to those described inU.S. Pat. No. 8,674,288, the subject matter of which is herebyincorporated by reference in its entirety.

In the illustrated embodiment of FIG. 1, the infusion device 102 isdesigned as a portable medical device suitable for infusing a fluid, aliquid, a gel, or other agent into the body of a user. In exemplaryembodiments, the infused fluid is insulin, although many other fluidsmay be administered through infusion such as, but not limited to, HIVdrugs, drugs to treat pulmonary hypertension, iron chelation drugs, painmedications, anti-cancer treatments, medications, vitamins, hormones, orthe like. In some embodiments, the fluid may include a nutritionalsupplement, a dye, a tracing medium, a saline medium, a hydrationmedium, or the like.

The sensing arrangement 104 generally represents the components of theinfusion system 100 configured to sense, detect, measure or otherwisequantify a condition of the user, and may include a sensor, a monitor,or the like, for providing data indicative of the condition that issensed, detected, measured or otherwise monitored by the sensingarrangement. In this regard, the sensing arrangement 104 may includeelectronics and enzymes reactive to a biological condition, such as ablood glucose level, or the like, of the user, and provide dataindicative of the blood glucose level to the infusion device 102, theCCD 106 and/or the computer 108. For example, the infusion device 102,the CCD 106 and/or the computer 108 may include a display for presentinginformation or data to the user based on the sensor data received fromthe sensing arrangement 104, such as, for example, a current glucoselevel of the user, a graph or chart of the user's glucose level versustime, device status indicators, alert messages, or the like. In otherembodiments, the infusion device 102, the CCD 106 and/or the computer108 may include electronics and software that are configured to analyzesensor data and operate the infusion device 102 to deliver fluid to thebody of the user based on the sensor data and/or preprogrammed deliveryroutines. Thus, in exemplary embodiments, one or more of the infusiondevice 102, the sensing arrangement 104, the CCD 106, and/or thecomputer 108 includes a transmitter, a receiver, and/or othertransceiver electronics that allow for communication with othercomponents of the infusion system 100, so that the sensing arrangement104 may transmit sensor data or monitor data to one or more of theinfusion device 102, the CCD 106 and/or the computer 108.

Still referring to FIG. 1, in various embodiments, the sensingarrangement 104 may be secured to the body of the user or embedded inthe body of the user at a location that is remote from the location atwhich the infusion device 102 is secured to the body of the user. Invarious other embodiments, the sensing arrangement 104 may beincorporated within the infusion device 102. In other embodiments, thesensing arrangement 104 may be separate and apart from the infusiondevice 102, and may be, for example, part of the CCD 106. In suchembodiments, the sensing arrangement 104 may be configured to receive abiological sample, analyte, or the like, to measure a condition of theuser.

As described above, in some embodiments, the CCD 106 and/or the computer108 may include electronics and other components configured to performprocessing, delivery routine storage, and to control the infusion device102 in a manner that is influenced by sensor data measured by and/orreceived from the sensing arrangement 104. By including controlfunctions in the CCD 106 and/or the computer 108, the infusion device102 may be made with more simplified electronics. However, in otherembodiments, the infusion device 102 may include all control functions,and may operate without the CCD 106 and/or the computer 108. In variousembodiments, the CCD 106 may be a portable electronic device. Inaddition, in various embodiments, the infusion device 102 and/or thesensing arrangement 104 may be configured to transmit data to the CCD106 and/or the computer 108 for display or processing of the data by theCCD 106 and/or the computer 108.

In some embodiments, the CCD 106 and/or the computer 108 may provideinformation to the user that facilitates the user's subsequent use ofthe infusion device 102. For example, the CCD 106 may provideinformation to the user to allow the user to determine the rate or doseof medication to be administered into the user's body. In otherembodiments, the CCD 106 may provide information to the infusion device102 to autonomously control the rate or dose of medication administeredinto the body of the user. In some embodiments, the sensing arrangement104 may be integrated into the CCD 106. Such embodiments may allow theuser to monitor a condition by providing, for example, a sample of hisor her blood to the sensing arrangement 104 to assess his or hercondition. In some embodiments, the sensing arrangement 104 and the CCD106 may be used for determining glucose levels in the blood and/or bodyfluids of the user without the use of, or necessity of, a wire or cableconnection between the infusion device 102 and the sensing arrangement104 and/or the CCD 106.

In some embodiments, the sensing arrangement 104 and/or the infusiondevice 102 are cooperatively configured to utilize a closed-loop systemfor delivering fluid to the user. Examples of sensing devices and/orinfusion pumps utilizing closed-loop systems may be found at, but arenot limited to, the following U.S. Pat. Nos. 6,088,608, 6,119,028,6,589,229, 6,740,072, 6,827,702, 7,323,142, and 7,402,153, all of whichare incorporated herein by reference in their entirety. In suchembodiments, the sensing arrangement 104 is configured to sense ormeasure a condition of the user, such as, blood glucose level or thelike. The infusion device 102 is configured to deliver fluid in responseto the condition sensed by the sensing arrangement 104. In turn, thesensing arrangement 104 continues to sense or otherwise quantify acurrent condition of the user, thereby allowing the infusion device 102to deliver fluid continuously in response to the condition currently (ormost recently) sensed by the sensing arrangement 104 indefinitely. Insome embodiments, the sensing arrangement 104 and/or the infusion device102 may be configured to utilize the closed-loop system only for aportion of the day, for example only when the user is asleep or awake.

FIGS. 2-4 depict one exemplary embodiment of a fluid infusion device 200(or alternatively, infusion pump) suitable for use in an infusionsystem, such as, for example, as infusion device 102 in the infusionsystem 100 of FIG. 1. The fluid infusion device 200 is a portablemedical device designed to be carried or worn by a patient (or user),and the fluid infusion device 200 may leverage any number ofconventional features, components, elements, and characteristics ofexisting fluid infusion devices, such as, for example, some of thefeatures, components, elements, and/or characteristics described in U.S.Pat. Nos. 6,485,465 and 7,621,893. It should be appreciated that FIGS.2-4 depict some aspects of the infusion device 200 in a simplifiedmanner; in practice, the infusion device 200 could include additionalelements, features, or components that are not shown or described indetail herein.

As best illustrated in FIGS. 2-3, the illustrated embodiment of thefluid infusion device 200 includes a housing 202 adapted to receive afluid-containing reservoir 205. An opening 220 in the housing 202accommodates a fitting 223 (or cap) for the reservoir 205, with thefitting 223 being configured to mate or otherwise interface with tubing221 of an infusion set 225 that provides a fluid path to/from the bodyof the user. In this manner, fluid communication from the interior ofthe reservoir 205 to the user is established via the tubing 221. Theillustrated fluid infusion device 200 includes a human-machine interface(HMI) 230 (or user interface) that includes elements 232, 234 that canbe manipulated by the user to administer a bolus of fluid (e.g.,insulin), to change therapy settings, to change user preferences, toselect display features, and the like. The infusion device also includesa display element 226, such as a liquid crystal display (LCD) or anothersuitable display element, that can be used to present various types ofinformation or data to the user, such as, without limitation: thecurrent glucose level of the patient; the time; a graph or chart of thepatient's glucose level versus time; device status indicators; etc.

The housing 202 is formed from a substantially rigid material having ahollow interior 214 adapted to allow an electronics assembly 204, asliding member (or slide) 206, a drive system 208, a sensor assembly210, and a drive system capping member 212 to be disposed therein inaddition to the reservoir 205, with the contents of the housing 202being enclosed by a housing capping member 216. The opening 220, theslide 206, and the drive system 208 are coaxially aligned in an axialdirection (indicated by arrow 218), whereby the drive system 208facilitates linear displacement of the slide 206 in the axial direction218 to dispense fluid from the reservoir 205 (after the reservoir 205has been inserted into opening 220), with the sensor assembly 210 beingconfigured to measure axial forces (e.g., forces aligned with the axialdirection 218) exerted on the sensor assembly 210 responsive tooperating the drive system 208 to displace the slide 206. In variousembodiments, the sensor assembly 210 may be utilized to detect one ormore of the following: an occlusion in a fluid path that slows,prevents, or otherwise degrades fluid delivery from the reservoir 205 toa user's body; when the reservoir 205 is empty; when the slide 206 isproperly seated with the reservoir 205; when a fluid dose has beendelivered; when the infusion pump 200 is subjected to shock orvibration; when the infusion pump 200 requires maintenance.

Depending on the embodiment, the fluid-containing reservoir 205 may berealized as a syringe, a vial, a cartridge, a bag, or the like. Incertain embodiments, the infused fluid is insulin, although many otherfluids may be administered through infusion such as, but not limited to,HIV drugs, drugs to treat pulmonary hypertension, iron chelation drugs,pain medications, anti-cancer treatments, medications, vitamins,hormones, or the like. As best illustrated in FIGS. 3-4, the reservoir205 typically includes a reservoir barrel 219 that contains the fluidand is concentrically and/or coaxially aligned with the slide 206 (e.g.,in the axial direction 218) when the reservoir 205 is inserted into theinfusion pump 200. The end of the reservoir 205 proximate the opening220 may include or otherwise mate with the fitting 223, which securesthe reservoir 205 in the housing 202 and prevents displacement of thereservoir 205 in the axial direction 218 with respect to the housing 202after the reservoir 205 is inserted into the housing 202. As describedabove, the fitting 223 extends from (or through) the opening 220 of thehousing 202 and mates with tubing 221 to establish fluid communicationfrom the interior of the reservoir 205 (e.g., reservoir barrel 219) tothe user via the tubing 221 and infusion set 225. The opposing end ofthe reservoir 205 proximate the slide 206 includes a plunger 217 (orstopper) positioned to push fluid from inside the barrel 219 of thereservoir 205 along a fluid path through tubing 221 to a user. The slide206 is configured to mechanically couple or otherwise engage with theplunger 217, thereby becoming seated with the plunger 217 and/orreservoir 205. Fluid is forced from the reservoir 205 via tubing 221 asthe drive system 208 is operated to displace the slide 206 in the axialdirection 218 toward the opening 220 in the housing 202.

In the illustrated embodiment of FIGS. 3-4, the drive system 208includes a motor assembly 207 and a drive screw 209. The motor assembly207 includes a motor that is coupled to drive train components of thedrive system 208 that are configured to convert rotational motor motionto a translational displacement of the slide 206 in the axial direction218, and thereby engaging and displacing the plunger 217 of thereservoir 205 in the axial direction 218. In some embodiments, the motorassembly 207 may also be powered to translate the slide 206 in theopposing direction (e.g., the direction opposite direction 218) toretract and/or detach from the reservoir 205 to allow the reservoir 205to be replaced. In exemplary embodiments, the motor assembly 207includes a brushless DC (BLDC) motor having one or more permanentmagnets mounted, affixed, or otherwise disposed on its rotor. However,the subject matter described herein is not necessarily limited to usewith BLDC motors, and in alternative embodiments, the motor may berealized as a solenoid motor, an AC motor, a stepper motor, apiezoelectric caterpillar drive, a shape memory actuator drive, anelectrochemical gas cell, a thermally driven gas cell, a bimetallicactuator, or the like. The drive train components may comprise one ormore lead screws, cams, ratchets, jacks, pulleys, pawls, clamps, gears,nuts, slides, bearings, levers, beams, stoppers, plungers, sliders,brackets, guides, bearings, supports, bellows, caps, diaphragms, bags,heaters, or the like. In this regard, although the illustratedembodiment of the infusion pump utilizes a coaxially aligned drivetrain, the motor could be arranged in an offset or otherwise non-coaxialmanner, relative to the longitudinal axis of the reservoir 205.

As best shown in FIG. 4, the drive screw 209 mates with threads 402internal to the slide 206. When the motor assembly 207 is powered andoperated, the drive screw 209 rotates, and the slide 206 is forced totranslate in the axial direction 218. In an exemplary embodiment, theinfusion pump 200 includes a sleeve 211 to prevent the slide 206 fromrotating when the drive screw 209 of the drive system 208 rotates. Thus,rotation of the drive screw 209 causes the slide 206 to extend orretract relative to the drive motor assembly 207. When the fluidinfusion device is assembled and operational, the slide 206 contacts theplunger 217 to engage the reservoir 205 and control delivery of fluidfrom the infusion pump 200. In an exemplary embodiment, the shoulderportion 215 of the slide 206 contacts or otherwise engages the plunger217 to displace the plunger 217 in the axial direction 218. Inalternative embodiments, the slide 206 may include a threaded tip 213capable of being detachably engaged with internal threads 404 on theplunger 217 of the reservoir 205, as described in detail in U.S. Pat.Nos. 6,248,093 and 6,485,465, which are incorporated by referenceherein.

As illustrated in FIG. 3, the electronics assembly 204 includes controlelectronics 224 coupled to the display element 226, with the housing 202including a transparent window portion 228 that is aligned with thedisplay element 226 to allow the display 226 to be viewed by the userwhen the electronics assembly 204 is disposed within the interior 214 ofthe housing 202. The control electronics 224 generally represent thehardware, firmware, processing logic and/or software (or combinationsthereof) configured to control operation of the motor assembly 207and/or drive system 208, as described in greater detail below in thecontext of FIG. 5. Whether such functionality is implemented ashardware, firmware, a state machine, or software depends upon theparticular application and design constraints imposed on the embodiment.Those familiar with the concepts described here may implement suchfunctionality in a suitable manner for each particular application, butsuch implementation decisions should not be interpreted as beingrestrictive or limiting. In an exemplary embodiment, the controlelectronics 224 includes one or more programmable controllers that maybe programmed to control operation of the infusion pump 200.

The motor assembly 207 includes one or more electrical leads 236 adaptedto be electrically coupled to the electronics assembly 204 to establishcommunication between the control electronics 224 and the motor assembly207. In response to command signals from the control electronics 224that operate a motor driver (e.g., a power converter) to regulate theamount of power supplied to the motor from a power supply, the motoractuates the drive train components of the drive system 208 to displacethe slide 206 in the axial direction 218 to force fluid from thereservoir 205 along a fluid path (including tubing 221 and an infusionset), thereby administering doses of the fluid contained in thereservoir 205 into the user's body. Preferably, the power supply isrealized one or more batteries contained within the housing 202.Alternatively, the power supply may be a solar panel, capacitor, AC orDC power supplied through a power cord, or the like. In someembodiments, the control electronics 224 may operate the motor of themotor assembly 207 and/or drive system 208 in a stepwise manner,typically on an intermittent basis; to administer discrete precise dosesof the fluid to the user according to programmed delivery profiles.

Referring to FIGS. 2-4, as described above, the user interface 230includes HMI elements, such as buttons 232 and a directional pad 234,that are formed on a graphic keypad overlay 231 that overlies a keypadassembly 233, which includes features corresponding to the buttons 232,directional pad 234 or other user interface items indicated by thegraphic keypad overlay 231. When assembled, the keypad assembly 233 iscoupled to the control electronics 224, thereby allowing the HMIelements 232, 234 to be manipulated by the user to interact with thecontrol electronics 224 and control operation of the infusion pump 200,for example, to administer a bolus of insulin, to change therapysettings, to change user preferences, to select display features, to setor disable alarms and reminders, and the like. In this regard, thecontrol electronics 224 maintains and/or provides information to thedisplay 226 regarding program parameters, delivery profiles, pumpoperation, alarms, warnings, statuses, or the like, which may beadjusted using the HMI elements 232, 234. In various embodiments, theHMI elements 232, 234 may be realized as physical objects (e.g.,buttons, knobs, joysticks, and the like) or virtual objects (e.g., usingtouch-sensing and/or proximity-sensing technologies). For example, insome embodiments, the display 226 may be realized as a touch screen ortouch-sensitive display, and in such embodiments, the features and/orfunctionality of the HMI elements 232, 234 may be integrated into thedisplay 226 and the HMI 230 may not be present. In some embodiments, theelectronics assembly 204 may also include alert generating elementscoupled to the control electronics 224 and suitably configured togenerate one or more types of feedback, such as, without limitation:audible feedback; visual feedback; haptic (physical) feedback; or thelike.

Referring to FIGS. 3-4, in accordance with one or more embodiments, thesensor assembly 210 includes a back plate structure 250 and a loadingelement 260. The loading element 260 is disposed between the cappingmember 212 and a beam structure 270 that includes one or more beamshaving sensing elements disposed thereon that are influenced bycompressive force applied to the sensor assembly 210 that deflects theone or more beams, as described in greater detail in U.S. Pat. No.8,474,332, which is incorporated by reference herein. In exemplaryembodiments, the back plate structure 250 is affixed, adhered, mounted,or otherwise mechanically coupled to the bottom surface 238 of the drivesystem 208 such that the back plate structure 250 resides between thebottom surface 238 of the drive system 208 and the housing cap 216. Thedrive system capping member 212 is contoured to accommodate and conformto the bottom of the sensor assembly 210 and the drive system 208. Thedrive system capping member 212 may be affixed to the interior of thehousing 202 to prevent displacement of the sensor assembly 210 in thedirection opposite the direction of force provided by the drive system208 (e.g., the direction opposite direction 218). Thus, the sensorassembly 210 is positioned between the motor assembly 207 and secured bythe capping member 212, which prevents displacement of the sensorassembly 210 in a downward direction opposite the direction of arrow218, such that the sensor assembly 210 is subjected to a reactionarycompressive force when the drive system 208 and/or motor assembly 207 isoperated to displace the slide 206 in the axial direction 218 inopposition to the fluid pressure in the reservoir 205. Under normaloperating conditions, the compressive force applied to the sensorassembly 210 is correlated with the fluid pressure in the reservoir 205.As shown, electrical leads 240 are adapted to electrically couple thesensing elements of the sensor assembly 210 to the electronics assembly204 to establish communication to the control electronics 224, whereinthe control electronics 224 are configured to measure, receive, orotherwise obtain electrical signals from the sensing elements of thesensor assembly 210 that are indicative of the force applied by thedrive system 208 in the axial direction 218.

FIG. 5 depicts an exemplary embodiment of a control system 500 suitablefor use with an infusion device 502, such as the infusion device 102 inFIG. 1 or the infusion device 200 of FIG. 2. The control system 500 isconfigured to control or otherwise regulate a physiological condition inthe body 501 of a user. In one or more exemplary embodiments, thecondition being regulated is sensed, detected, measured or otherwisequantified by a sensing arrangement 504 (e.g., sensing arrangement 104)communicatively coupled to the infusion device 502. However, it shouldbe noted that in alternative embodiments, the condition being regulatedby the control system 500 may be correlative to the measured valuesobtained by the sensing arrangement 504. That said, for clarity andpurposes of explanation, the subject matter may be described herein inthe context of the sensing arrangement 504 being realized as a glucosesensing arrangement that senses, detects, measures or otherwisequantifies the user's glucose level, which is being regulated in thebody 501 of the user by the control system 500.

In exemplary embodiments, the sensing arrangement 504 includes one ormore interstitial glucose sensing elements that generate or otherwiseoutput electrical signals having a signal characteristic that iscorrelative to, influenced by, or otherwise indicative of the relativeinterstitial fluid glucose level in the body 501 of the user. The outputelectrical signals are filtered or otherwise processed to obtain ameasurement value indicative of the user's interstitial fluid glucoselevel. In exemplary embodiments, a blood glucose meter 530, such as afinger stick device, is utilized to directly sense, detect, measure orotherwise quantify the blood glucose in the body 501 of the user. Inthis regard, the blood glucose meter 530 outputs or otherwise provides ameasured blood glucose value that may be utilized as a referencemeasurement for calibrating the sensing arrangement 504 and converting ameasurement value indicative of the user's interstitial fluid glucoselevel into a corresponding calibrated blood glucose measurement value.For purposes of explanation, sensor glucose value, sensed glucose value,or variants thereof should be understood to encompass any glucose valueindicative of a current glucose level in the body of the user that isbased on the electrical signals output by the sensing element(s) of thesensing arrangement 504.

The pump control system 520 generally represents the electronics andother components of the infusion device 502 that control operation ofthe fluid infusion device 502 according to a desired infusion deliveryprogram in a manner that may be influenced by the sensed glucose valueindicative of a current glucose level in the body 501 of the user. Theparticular operating mode being implemented by the pump control system520 influences the generated dosage commands for operating the motor 507to displace the plunger 517 and deliver insulin to the body 501 of theuser. For example, in a closed-loop (CL) operating mode, the pumpcontrol system 520 generates or otherwise determines dosage commands foroperating the motor 507 based on the difference between a sensed glucosevalue and the target (or commanded) glucose value to regulate the sensedglucose value to the target. In other operating modes, the pump controlsystem 520 may generate or otherwise determine dosage commandsconfigured to maintain the sensed glucose value below an upper glucoselimit, above a lower glucose limit, or otherwise within a desired rangeof glucose values. For example, in a predictive low glucose management(PLGM) operating mode, the pump control system 520 calculates orotherwise determines a predicted glucose value based on the currentlysensed glucose value, and generates dosage commands configured toprovide a basal infusion rate when the predicted glucose value isgreater than a predictive suspend threshold and automatically suspendsdelivery (e.g., by providing dosage commands equal to zero) when thepredicted glucose value is less than the predictive suspend threshold.In a low glucose suspend (LGS) operating mode, the pump control system520 generates dosage commands configured to provide a basal infusionrate when the sensed glucose value is greater than a suspend threshold(which may be different from the predictive suspend threshold) andautomatically suspends delivery when the sensed glucose value is lessthan the suspend threshold. In an open-loop (OL) operating mode, thepump control system 520 generates dosage commands configured to providea predetermined open-loop basal infusion rate independent of the sensedglucose value. In practice, the infusion device 502 may store orotherwise maintain the target value, suspension threshold values, and/orother glucose threshold value(s) in a data storage element accessible tothe pump control system 520.

The target glucose value and other threshold values may be received froman external component (e.g., CCD 106 and/or computing device 108) or beinput by a user via a user interface element 540 associated with theinfusion device 502. In practice, the one or more user interfaceelement(s) 540 associated with the infusion device 502 typically includeat least one input user interface element, such as, for example, abutton, a keypad, a keyboard, a knob, a joystick, a mouse, a touchpanel, a touchscreen, a microphone or another audio input device, and/orthe like. Additionally, the one or more user interface element(s) 540include at least one output user interface element, such as, forexample, a display element (e.g., a light-emitting diode or the like), adisplay device (e.g., a liquid crystal display or the like), a speakeror another audio output device, a haptic feedback device, or the like,for providing notifications or other information to the user. It shouldbe noted that although FIG. 5 depicts the user interface element(s) 540as being separate from the infusion device 502, in practice, one or moreof the user interface element(s) 540 may be integrated with the infusiondevice 502. Furthermore, in some embodiments, one or more user interfaceelement(s) 540 are integrated with the sensing arrangement 504 inaddition to and/or in alternative to the user interface element(s) 540integrated with the infusion device 502. The user interface element(s)540 may be manipulated by the user to operate the infusion device 502 todeliver correction boluses, adjust target and/or threshold values,modify the delivery control scheme or operating mode, and the like, asdesired.

In exemplary embodiments, the pump control system 520 includes orotherwise accesses a data storage element, memory, or othernon-transitory computer-readable medium capable of storing programminginstructions for execution by the pump control system 520. Thecomputer-executable programming instructions, when read and executed,cause the pump control system 520 to determine dosage commands inaccordance with a particular operating mode and perform variousadditional tasks, operations, functions, and processes described hereinin the context of FIGS. 7-10.

Still referring to FIG. 5, in the illustrated embodiment, the infusiondevice 502 includes a motor control module 512 coupled to a motor 507(e.g., motor assembly 207) that is operable to displace a plunger 517(e.g., plunger 217) in a reservoir (e.g., reservoir 205) and provide adesired amount of fluid to the body 501 of a user. In this regard,displacement of the plunger 517 results in the delivery of a fluid thatis capable of influencing the condition in the body 501 of the user tothe body 501 of the user via a fluid delivery path (e.g., via tubing 221of an infusion set 225). A motor driver module 514 is coupled between anenergy source 503 and the motor 507. The motor control module 512 iscoupled to the motor driver module 514, and the motor control module 512generates or otherwise provides command signals that operate the motordriver module 514 to provide current (or power) from the energy source503 to the motor 507 to displace the plunger 517 in response toreceiving, from a pump control system 520, a dosage command indicativeof the desired amount of fluid to be delivered.

In exemplary embodiments, the energy source 503 is realized as a batteryhoused within the infusion device 502 (e.g., within housing 202) thatprovides direct current (DC) power. In this regard, the motor drivermodule 514 generally represents the combination of circuitry, hardwareand/or other electrical components configured to convert or otherwisetransfer DC power provided by the energy source 503 into alternatingelectrical signals applied to respective phases of the stator windingsof the motor 507 that result in current flowing through the statorwindings that generates a stator magnetic field and causes the rotor ofthe motor 507 to rotate. The motor control module 512 is configured toreceive or otherwise obtain a commanded dosage from the pump controlsystem 520, convert the commanded dosage to a commanded translationaldisplacement of the plunger 517, and command, signal, or otherwiseoperate the motor driver module 514 to cause the rotor of the motor 507to rotate by an amount that produces the commanded translationaldisplacement of the plunger 517. For example, the motor control module512 may determine an amount of rotation of the rotor required to producetranslational displacement of the plunger 517 that achieves thecommanded dosage received from the pump control system 520. Based on thecurrent rotational position (or orientation) of the rotor with respectto the stator that is indicated by the output of the rotor sensingarrangement 516, the motor control module 512 determines the appropriatesequence of alternating electrical signals to be applied to therespective phases of the stator windings that should rotate the rotor bythe determined amount of rotation from its current position (ororientation). In embodiments where the motor 507 is realized as a BLDCmotor, the alternating electrical signals commutate the respectivephases of the stator windings at the appropriate orientation of therotor magnetic poles with respect to the stator and in the appropriateorder to provide a rotating stator magnetic field that rotates the rotorin the desired direction. Thereafter, the motor control module 512operates the motor driver module 514 to apply the determined alternatingelectrical signals (e.g., the command signals) to the stator windings ofthe motor 507 to achieve the desired delivery of fluid to the user.

When the motor control module 512 is operating the motor driver module514, current flows from the energy source 503 through the statorwindings of the motor 507 to produce a stator magnetic field thatinteracts with the rotor magnetic field. In some embodiments, after themotor control module 512 operates the motor driver module 514 and/ormotor 507 to achieve the commanded dosage, the motor control module 512ceases operating the motor driver module 514 and/or motor 507 until asubsequent dosage command is received. In this regard, the motor drivermodule 514 and the motor 507 enter an idle state during which the motordriver module 514 effectively disconnects or isolates the statorwindings of the motor 507 from the energy source 503. In other words,current does not flow from the energy source 503 through the statorwindings of the motor 507 when the motor 507 is idle, and thus, themotor 507 does not consume power from the energy source 503 in the idlestate, thereby improving efficiency.

Depending on the embodiment, the motor control module 512 may beimplemented or realized with a general purpose processor, amicroprocessor, a controller, a microcontroller, a state machine, acontent addressable memory, an application specific integrated circuit,a field programmable gate array, any suitable programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination thereof, designed to perform the functions described herein.Furthermore, the steps of a method or algorithm described in connectionwith the embodiments disclosed herein may be embodied directly inhardware, in firmware, in a software module executed by the motorcontrol module 512, or in any practical combination thereof. Inexemplary embodiments, the motor control module 512 includes orotherwise accesses a data storage element or memory, including any sortof random access memory (RAM), read only memory (ROM), flash memory,registers, hard disks, removable disks, magnetic or optical massstorage, or any other short or long term storage media or othernon-transitory computer-readable medium, which is capable of storingprogramming instructions for execution by the motor control module 512.The computer-executable programming instructions, when read and executedby the motor control module 512, cause the motor control module 512 toperform the tasks, operations, functions, and processes describedherein.

It should be appreciated that FIG. 5 is a simplified representation ofthe infusion device 502 for purposes of explanation and is not intendedto limit the subject matter described herein in any way. In this regard,depending on the embodiment, some features and/or functionality of thesensing arrangement 504 may be implemented by or otherwise integratedinto the pump control system 520, or vice versa. Similarly, in practice,the features and/or functionality of the motor control module 512 may beimplemented by or otherwise integrated into the pump control system 520,or vice versa. Furthermore, the features and/or functionality of thepump control system 520 may be implemented by control electronics 224located in the fluid infusion device 200, while in alternativeembodiments, the pump control system 520 may be implemented by a remotecomputing device that is physically distinct and/or separate from theinfusion device 502, such as, for example, the CCD 106 or the computingdevice 108.

FIG. 6 depicts an exemplary embodiment of a pump control system 600suitable for use as the pump control system 520 in FIG. 5 in accordancewith one or more embodiments. The illustrated pump control system 600includes, without limitation, a pump control module 602, acommunications interface 604, and a data storage element (or memory)606. The pump control module 602 is coupled to the communicationsinterface 604 and the memory 606, and the pump control module 602 issuitably configured to support the operations, tasks, and/or processesdescribed herein. In exemplary embodiments, the pump control module 602is also coupled to one or more user interface elements 608 (e.g., userinterface 230, 540) for receiving bolus or other delivery instructionsand providing notifications or other information to the user. AlthoughFIG. 6 depicts the user interface element 608 as being integrated withthe pump control system 600 (e.g., as part of the infusion device 200,502), in various alternative embodiments, the user interface element 608may be integrated with the sensing arrangement 504 or another element ofan infusion system 100 (e.g., the computer 108 or CCD 106).

Referring to FIG. 6 and with reference to FIG. 5, the communicationsinterface 604 generally represents the hardware, circuitry, logic,firmware and/or other components of the pump control system 600 that arecoupled to the pump control module 602 and configured to supportcommunications between the pump control system 600 and the sensingarrangement 504. In this regard, the communications interface 604 mayinclude or otherwise be coupled to one or more transceiver modulescapable of supporting wireless communications between the pump controlsystem 520, 600 and the sensing arrangement 504 or another electronicdevice 106, 108 in an infusion system 100. In other embodiments, thecommunications interface 604 may be configured to support wiredcommunications to/from the sensing arrangement 504.

The pump control module 602 generally represents the hardware,circuitry, logic, firmware and/or other component of the pump controlsystem 600 that is coupled to the communications interface 604 andconfigured to determine dosage commands for operating the motor 507 todeliver fluid to the body 501 based on data received from the sensingarrangement 504 and perform various additional tasks, operations,functions and/or operations described herein. For example, in exemplaryembodiments, pump control module 602 implements or otherwise executes acommand generation module 614 that automatically calculates or otherwisedetermines a dosage command for operating the motor 507 of the infusiondevice 502 in accordance with a particular operating mode. In exemplaryembodiments described herein, the command generation module 614 supportsmultiple different operating modes having different delivery controlschemes associated therewith. Additionally, the command generationmodule 614 may generate dosage commands for delivering boluses that aremanually-initiated or otherwise instructed by a user via a userinterface element 608. The illustrated pump control module 602 alsoimplements or otherwise executes a diagnostics module 612 that generatesor otherwise provides user notifications or alerts via a user interfaceelement 608. As described in greater detail below in the context of FIG.8, in exemplary embodiments, the diagnostics module 612 determines theviability of a particular operating mode in advance of a subsequentinstance of that operating mode and generates notifications via the userinterface element 608 that indicate recommended remedial actions toimprove the viability of that operating mode.

Still referring to FIG. 6, depending on the embodiment, the pump controlmodule 602 may be implemented or realized with a general purposeprocessor, a microprocessor, a controller, a microcontroller, a statemachine, a content addressable memory, an application specificintegrated circuit, a field programmable gate array, any suitableprogrammable logic device, discrete gate or transistor logic, discretehardware components, or any combination thereof, designed to perform thefunctions described herein. In this regard, the steps of a method oralgorithm described in connection with the embodiments disclosed hereinmay be embodied directly in hardware, in firmware, in a software moduleexecuted by the pump control module 602, or in any practical combinationthereof. In exemplary embodiments, the pump control module 602 includesor otherwise accesses the data storage element or memory 606, which maybe realized using any sort of non-transitory computer-readable mediumcapable of storing programming instructions for execution by the pumpcontrol module 602. The computer-executable programming instructions,when read and executed by the pump control module 602, cause the pumpcontrol module 602 to perform the tasks, operations, functions, andprocesses described in greater detail below.

It should be understood that FIG. 6 is a simplified representation of apump control system 600 for purposes of explanation and is not intendedto limit the subject matter described herein in any way. For example, insome embodiments, the features and/or functionality of the motor controlmodule 512 may be implemented by or otherwise integrated into the pumpcontrol system 600 and/or the pump control module 602, for example, bythe command generation module 614 converting the dosage command into acorresponding motor command, in which case, the separate motor controlmodule 512 may be absent from an embodiment of the infusion device 502.

FIG. 7 depicts an exemplary closed-loop control system 700 that may beimplemented by a pump control system 520, 600 to regulate a condition inthe body of a user to a desired (or target) value. It should beappreciated that FIG. 7 is a simplified representation of the controlsystem 700 for purposes of explanation and is not intended to limit thesubject matter described herein in any way.

In exemplary embodiments, the control system 700 receives or otherwiseobtains a target glucose value at input 702. In some embodiments, thetarget glucose value may be stored or otherwise maintained by theinfusion device 502 (e.g., in memory 606), however, in some alternativeembodiments, the target value may be received from an external component(e.g., CCD 106 and/or computer 108). In one or more embodiments, thetarget glucose value may be dynamically calculated or otherwisedetermined prior to entering the closed-loop operating mode based on oneor more patient-specific control parameters. For example, the targetblood glucose value may be calculated based at least in part on apatient-specific reference basal rate and a patient-specific dailyinsulin requirement, which are determined based on historical deliveryinformation over a preceding interval of time (e.g., the amount ofinsulin delivered over the preceding 24 hours). The control system 700also receives or otherwise obtains a current glucose measurement valuefrom the sensing arrangement 504 at input 704. The illustrated controlsystem 700 implements or otherwise providesproportional-integral-derivative (PID) control to determine or otherwisegenerate delivery commands for operating the motor 507 based at least inpart on the difference between the target glucose value and the currentglucose measurement value. In this regard, the PID control attempts tominimize the difference between the measured value and the target value,and thereby regulates the measured value to the desired value. PIDcontrol parameters are applied to the difference between the targetglucose level at input 702 and the measured glucose level at input 704to generate or otherwise determine a dosage (or delivery) commandprovided at output 730. Based on that delivery command, the motorcontrol module 512 operates the motor 507 to deliver insulin to the bodyof the user to influence the user's glucose level, and thereby reducethe difference between a subsequently measured glucose level and thetarget glucose level.

The illustrated control system 700 includes or otherwise implements asummation block 706 configured to determine a difference between thetarget value obtained at input 702 and the measured value obtained fromthe sensing arrangement 504 at input 704, for example, by subtractingthe target value from the measured value. The output of the summationblock 706 represents the difference between the measured and targetvalues, which is then provided to each of a proportional term path, anintegral term path, and a derivative term path. The proportional termpath includes a gain block 720 that multiplies the difference by aproportional gain coefficient, K_(P), to obtain the proportional term.The integral term path includes an integration block 708 that integratesthe difference and a gain block 722 that multiplies the integrateddifference by an integral gain coefficient, K_(I), to obtain theintegral term. The derivative term path includes a derivative block 710that determines the derivative of the difference and a gain block 724that multiplies the derivative of the difference by a derivative gaincoefficient, K_(D), to obtain the derivative term. The proportionalterm, the integral term, and the derivative term are then added orotherwise combined to obtain a delivery command that is utilized tooperate the motor at output 730. Various implementation detailspertaining to closed-loop PID control and determine gain coefficientsare described in greater detail in U.S. Pat. No. 7,402,153, which isincorporated by reference.

In one or more exemplary embodiments, the PID gain coefficients areuser-specific (or patient-specific) and dynamically calculated orotherwise determined prior to entering the closed-loop operating modebased on historical insulin delivery information (e.g., amounts and/ortimings of previous dosages, historical correction bolus information, orthe like), historical sensor measurement values, historical referenceblood glucose measurement values, user-reported or user-input events(e.g., meals, exercise, and the like), and the like. In this regard, oneor more patient-specific control parameters (e.g., an insulinsensitivity factor, a daily insulin requirement, an insulin limit, areference basal rate, a reference fasting glucose, an active insulinaction duration, pharmodynamical time constants, or the like) may beutilized to compensate, correct, or otherwise adjust the PID gaincoefficients to account for various operating conditions experiencedand/or exhibited by the infusion device 502. The PID gain coefficientsmay be maintained by the memory 606 accessible to the pump controlmodule 602. In this regard, the memory 606 may include a plurality ofregisters associated with the control parameters for the PID control.For example, a first parameter register may store the target glucosevalue and be accessed by or otherwise coupled to the summation block 706at input 702, and similarly, a second parameter register accessed by theproportional gain block 720 may store the proportional gain coefficient,a third parameter register accessed by the integration gain block 722may store the integration gain coefficient, and a fourth parameterregister accessed by the derivative gain block 724 may store thederivative gain coefficient.

FIG. 8 depicts an exemplary transition diagnosis process 800 suitablefor implementation by a control system associated with a fluid infusiondevice to determine whether transitioning into a particular operatingmode at some subsequent time is viable. For purposes of explanation, thetransition diagnosis process 800 may be described herein in the contextof a closed-loop operating mode, however, it will be appreciated thatthe subject matter described herein is not limited to the particulardestination operating mode being diagnosed. Various tasks performed inconnection with the transition diagnosis process 800 may be performed byhardware, firmware, software executed by processing circuitry, or anycombination thereof. For illustrative purposes, the followingdescription refers to elements mentioned above in connection with FIGS.1-7. In practice, portions of the transition diagnosis process 800 maybe performed by different elements of the control system 500, such as,for example, the infusion device 502, the pump control system 520, 600,the diagnostics module 612, the command generation module 614 and/or theuser interface 540, 608. It should be appreciated that the transitiondiagnosis process 800 may include any number of additional oralternative tasks, the tasks need not be performed in the illustratedorder and/or the tasks may be performed concurrently, and/or thetransition diagnosis process 800 may be incorporated into a morecomprehensive procedure or process having additional functionality notdescribed in detail herein. Moreover, one or more of the tasks shown anddescribed in the context of FIG. 8 could be omitted from a practicalembodiment of the transition diagnosis process 800 as long as theintended overall functionality remains intact.

In the illustrated embodiment, the transition diagnosis process 800initializes or otherwise begins by obtaining operational informationpertaining to one or more prior instances of the operating mode beinganalyzed and calculates or otherwise determines an expected start timeand an expected duration of the next subsequent instance of theoperating mode based on the operational information for the priorinstances (tasks 802, 804). In this regard, the pump control system 520,600 may store or otherwise maintain historical information pertaining tothe previous operation of the infusion device 502 that characterizesprior instances of the different operating modes supported by the pumpcontrol system 520, 600. For example, the pump control system 520 maystore or otherwise maintain operational information indicative of therespective start times of prior instances of the closed-loop operatingmode along with the respective durations (or stop times) of priorinstances of the closed-loop operating mode. Based on this historicaloperational information maintained for the closed-loop operating mode,the pump control system 520, 600 and/or diagnostics module 612 maydetermine an expected (or anticipated) start time for a subsequentinstance of the closed-loop operating mode along with an expectedduration for the subsequent instance of the closed-loop operating mode.For example, the expected start time may be calculated by averaging theindividual start times for preceding instances of the closed-loopoperating mode, and the expected duration may be calculated by averagingthe respective durations of preceding instances of the closed-loopoperating mode.

In exemplary embodiments, the transition diagnosis process 800calculates or otherwise determines a buffer time before the subsequentinstance of the destination operating mode is expected to be initiated(task 806). The buffer time represents the amount of time in advance ofthe expected start time for analyzing the future viability of enteringthe destination operating mode at the expected start time. In exemplaryembodiments, the buffer time is determined so that it providessufficient time for remedial actions to be undertaken to improve theviability the destination operating mode by the expected start time. Forexample, calculating the PID control parameters for the closed-loopoperating mode may require a certain amount of reference blood glucosemeasurements, sensor measurement data, insulin delivery information, orthe like. Accordingly, when the destination operating mode is theclosed-loop operating mode, the buffer time is chosen to provide enoughtime between the diagnostics checks and the expected start time for thenext instance of the closed-loop operating mode to allow the requiredamount of data for calculating the PID control parameters to be obtainedby the expected start time. In this regard, the buffer time may varydepending on the particular destination operating mode being analyzedand the respective algorithmic diagnostic checks to be performed forthat particular operating mode. For example, the buffer time for theclosed-loop operating mode may be greater than the buffer time for a LGSoperating mode due to the calculation of the closed-loop PID controlparameters requiring a greater amount of underlying data than the LGSoperating mode control parameters. In one embodiment, a five hour buffertime is utilized for the closed-loop operating mode to ensure historicaldelivery information sufficient for calculating patient-specific controlparameters will likely exist at the expected start time for theclosed-loop operating mode.

Additionally, the buffer time may vary dynamically depending on theiteration of the diagnosis process 800. For example, if previousiterations of the diagnosis process 800 have already determined thataspects of the destination operating mode that require a longer buffertime are unlikely to impact the future viability of the operating mode(e.g., sufficient historical data is available), the buffer time may bereduced for subsequent iterations of the diagnosis process 800. In oneor more embodiments, where the diagnostics module 612 analyzes theviability of the sensing arrangement 504 as part of determining theviability for the next instance of the destination operating mode, thebuffer time is determined to be greater than or equal to a minimumamount of time required to calibrate the sensing arrangement 504. Inthis regard, if a reliability or accuracy metric associated with thesensing arrangement 504 indicates a sensing element should be replaced,the buffer time ensures that there will be enough time to calibrate thesensing arrangement 504 with a new sensing element before the expectedstart time. In one embodiment, a minimum buffer time of two hours may beimplemented.

The diagnosis process 800 continues by automatically identifying orotherwise determining when to begin analyzing the viability of thedestination operating mode based on the buffer time and the expectedstart time (task 808). In this regard, at the buffer time before theexpected start time, the diagnosis process 800 obtains statusinformation for the operation of the infusion device and calculates orotherwise determines viability of a subsequent instance of the operatingmode based at least in part on that status information (tasks 810, 812).When one or more of the physical or algorithmic diagnostics checksindicates the destination operating mode is unlikely to be viable at theexpected start time for the expected duration, the diagnosis process 800automatically generates or otherwise provides one or more usernotifications indicative of recommended remedial actions for improvingthe future viability of the operating mode (tasks 814, 816). In thisregard, the diagnostics module 612 operates a user interface 540, 608 toprovide indication of a remedial action that the user can perform toincrease the likelihood that the operating mode will be viable at theexpected start time.

In exemplary embodiments, the diagnostics module 612 automaticallyobtains clinical and physical status information pertaining to thecurrent and/or previous operation of the infusion device 502 from thememory 606, such as, historical delivery data (e.g., timing and amountsof correction boluses, daily insulin delivered, etc.), blood glucosereference measurement data (e.g., measurement values obtained from bloodglucose meter 530 and the corresponding times of measurement), sensorcalibration data (e.g., current and/or previous calibration factors),recent sensor measurement data, the current status of the energy source503 (e.g., the current battery level), the current amount of fluidremaining in the reservoir, and the like. The diagnostics module 612analyzes the status information and determines the viability of thedestination operating mode for the expected duration of the nextinstance of the destination operating mode. When one or more aspects ofthe status information fail to satisfy a respective viability criterion,the diagnostics module 612 determines that the operating mode isunlikely to be viable at the expected start time for the expectedduration.

In exemplary embodiments, the diagnostics module 612 determines whetherimplementing the destination operating mode at the expected start timefor the expected duration is viable from a physical perspective. In thisregard, the diagnostics module 612 performs a number of physicaldiagnostics checks to verify the infusion device 502 is physicallycapable of implementing the destination operating mode at the expectedstart time for the expected duration. For example, the diagnosticsmodule 612 may calculate or otherwise determine an expected amount ofpower consumption for the infusion device 502 over the sum of theremaining buffer time before the expected start time and the expectedduration, and identifies or otherwise determines the infusion device 502is not viable for the destination operating mode when the currentbattery level is less than the expected amount of power consumption. Inthis regard, the diagnostics module 612 effectively determines whether alow battery alert that could disrupt or otherwise degrade the userexperience is likely to be generated by the infusion device 502 duringthe expected duration of the destination operating mode.

Similarly, the diagnostics module 612 may calculate an expected amountof insulin that will be delivered by the infusion device 502 over thesum of the remaining buffer time before the expected start time and theexpected duration based on the historical delivery data and the user'srecent sensor glucose measurement value(s), and determines the infusiondevice 502 is not viable for the destination operating mode when thecurrent amount of insulin remaining is less than the expected amount ofinsulin to be delivered. Thus, the diagnostics module 612 effectivelydetermines whether a low fluid alert is likely to be generated by theinfusion device 502 at some point during the expected duration of thedestination operating mode. The diagnostics module 612 may alsodetermine whether any other critical alerts are likely to be generatedduring the expected duration or whether any events or conditions arelikely to occur that would result in the destination operating modeautomatically being terminated during the expected duration. In suchembodiments, the diagnostics module 612 determines the infusion device502 is not viable for the destination operating mode when it isdetermined that a critical alert (or alternatively, a number of alertsexceeding a maximum alert threshold) or an automatic exit event islikely to occur during the expected duration.

In one or more embodiments, the diagnostics module 612 may alsocalculate or otherwise determine the viability of the sensingarrangement 504 for the expected duration. For example, the diagnosticsmodule 612 may calculate or otherwise determine one or more reliabilityor accuracy metrics associated with the sensing arrangement 504 based onrecent sensor measurement values, blood glucose reference measurementvalues and/or other calibration information. The diagnostics module 612determines a projected reliability or accuracy metrics during theexpected duration, and identifies or otherwise determines the sensingarrangement 504 is not viable for the destination operating mode whenthe value of a projected metric is less than a replacement thresholdvalue at any point during the expected duration. In this regard, thediagnostics module 612 effectively determines whether a replace sensoralert that could disrupt or otherwise degrade the user experience islikely to be generated by the infusion device 502 at some point duringthe expected duration. In other embodiments, the diagnostics module 612may determine the sensing arrangement 504 is not viable for thedestination operating mode if a difference between the current sensorglucose measurement value and a predicted glucose value is greater thana threshold value, a calibration factor for the sensing arrangement 504will have expired by the expected start time, communications with thesensing arrangement 504 are deteriorating (e.g., based on an increasingnumber or frequency of dropouts in communications over a preceding timeinterval), a difference between the current calibration factor and thepreceding calibration factor is greater than a threshold amount (e.g., adifference of more than 35%), or a difference between reference bloodglucose measurement value and the corresponding sensor measurement valueused for the current calibration factor is greater than a thresholdamount (e.g., the sensor measurement value is more than 35% greater thanor less than the reference blood glucose measurement value).Additionally, in some embodiments, the diagnostics module 612 may obtaina current battery level for the sensing arrangement 504, determine anexpected amount of power consumption for the sensing arrangement 504over the sum of the remaining buffer time before the expected start timeand the expected duration, and determine the sensing arrangement 504 isnot viable when its current battery level is less than that expectedamount of power consumption.

Additionally, the diagnostics module 612 performs a number ofalgorithmic diagnostics checks to determine the availability of thedestination operating mode at the expected start time. In this regard,the diagnostics module 612 determines the destination operating mode islikely to be unavailable if one or more control parameters relied on bythe delivery control scheme of the destination operating mode cannot becalculated, determined, or otherwise obtained at the expected starttime. Thus, if insufficient data exists for calculating a particularcontrol parameter, the diagnostics module 612 may determine that thedestination operating mode is likely to be unavailable, and thereforenot viable. For example, in one embodiment, the closed-loop operatingmode utilizes a maximum output insulin infusion rate (U/hr) that iscalculated based on the user's total daily insulin dose. When thediagnostics module 612 determines that the less than two consecutivepreceding days total daily insulin dose information exists, thediagnostics module 612 determines that the closed-loop operating modelikely will not be viable at the expected start time without a validmaximum output insulin infusion rate. In such situations, thediagnostics module 612 may generate a user notification to manuallyinput a maximum output insulin infusion rate (or alternatively, a totaldaily insulin dose). Thus, if the user would like to implement theclosed-loop operating mode at a subsequent time but is unsure of how toproceed, the user may contact his or her doctor or other healthcareprovider for assistance in determining the maximum output insulininfusion rate (or total daily insulin dose) that is most likely to suitthe user's individual needs and insulin response.

In exemplary embodiments, the diagnostics module 612 also determineswhether the control parameters will be valid for the entirety of theexpected duration of the next instance of the operating mode, and thediagnostics module 612 determines the destination operating mode is notlikely to be viable if a control parameter relied on by the deliverycontrol scheme is likely to become invalid at some point during theexpected duration. For example, the diagnostics module 612 may determinean infusion rate calculated based on predicted sensor glucose valueswill be invalid during the expected duration based on the expected rateor frequency of communications dropouts between the infusion device 502and the sensing arrangement 504.

In the case of a physical diagnostics check indicating theimplementation of the operating mode may not be viable for the expectedduration, the diagnostics module 612 recommends actions that the usercan perform to help ensure the infusion device 502 and the sensingarrangement 504 will be physically capable of implementing the operatingmode for the expected duration by the expected start time. For example,when the diagnostics module 612 determines the energy source 503 willlikely be unable to provide the expected amount of power consumption bythe infusion device 502 throughout the buffer time and the expectedduration, the diagnostics module 612 may generate or otherwise providean indication on a display device 540, 608 that recommends the userrecharge or replace the energy source 503. Thus, in advance of theexpected start time, the user may initiate replenishment of the energysource 503 so that its state of charge (or power capability) at theexpected start time exceeds the expected power consumption over theexpected duration. Similarly, when the diagnostics module 612 determinesthe fluid level of the reservoir is likely too low to provide theexpected amount of insulin that will need to be delivered over thebuffer time and the expected duration, the diagnostics module 612 maygenerate or otherwise provide an indication on a display device 540, 608that recommends the user refill or replace the fluid reservoir. Thus, inadvance of the expected start time, the user may replenish the reservoirof the infusion device 502 so that the amount of insulin onboard theinfusion device 502 at the expected start time exceeds the expectedinsulin delivery over the expected duration. Likewise, when thediagnostics module 612 determines the sensing arrangement 504 is likelyto require replacement, recalibration, or recharging, the diagnosticsmodule 612 may generate or otherwise provide the appropriatenotification to the user so that the user may recharge the sensingarrangement 504, replace the sensing element of the sensing arrangement504, recalibrate the sensing arrangement 504, or the like.

Likewise, in the case of an algorithmic diagnostics check indicating theimplementation of the operating mode may not be viable, the diagnosticsmodule 612 recommends actions that the user can perform to help ensurethe valid control parameters for the delivery control scheme associatedwith the destination operating mode will be able to be calculated at theexpected start time. For example, if calculating a control parameterrequires a particular number of blood glucose measurement values (or aparticular number of pairs of blood glucose measurement values andsensor glucose measurement values) over a preceding interval of time(e.g., the prior 12 hours) the diagnostics module 612 may generate orotherwise provide an indication to the user to obtain one or more bloodglucose measurement values via the blood glucose meter 530, so that theamount of blood glucose measurement data required for calculating thatcontrol parameter will be maintained by the infusion device 502 (e.g.,in memory 606) at the expected start time. In one embodiment, thediagnostics module 612 generates a notification to obtain a new bloodglucose measurement value via the blood glucose meter 530 in response todetermining that no reference blood glucose measurement value within 12hours of the expected start time is currently available.

In one embodiment, algorithmic diagnostics checks to determine theavailability of the destination operating mode at the expected starttime based on an expected duration of operation in another operatingmode (e.g., which may be the current operating mode). For example, ifthe user is returning from a pump vacation or other period ofnon-operation, it may be required that the infusion device 502 beoperated in an open-loop operating mode for a minimum period of time(e.g., 5 hours) to support calculating a plasma insulin estimate and/orother patient-specific parameters at the expected start time. In thisregard, the buffer time may be chosen to be greater than or equal to theminimum period of time for the open-loop operating mode, and thediagnostics module 612 may generate or otherwise provide an indicationto the user to operate the infusion device 502 in the open-loopoperating mode when the amount of time that the infusion device 502 hasbeen operated in the open-loop operating mode is less than the minimumperiod of time. In this regard, when the infusion device 502 iscurrently in the open-loop operating mode but has not been operated forthe minimum period of time, the diagnostics module 612 may calculate orotherwise determine an amount of time required to achieve the minimumperiod of time and generate or otherwise provide a notification to theuser that indicates how much longer the user should maintain theinfusion device 502 in the open-loop operating mode.

Still referring to FIG. 8, in the illustrated embodiment, when thediagnosis process 800 determines that the destination operating mode islikely to be viable at the expected start time for the expectedduration, the diagnosis process 800 may also automatically generate orotherwise provides an indication of the future viability of theoperating mode (task 818). For example, the diagnostics module 612 mayoperate a user interface 540, 608 to provide indication of the viabilityof the operating mode. In this regard, in situations where thedestination operating mode is manually-initiated, the user is providedwith a notification that lets the user know that the destinationoperating mode should be available to be initiated as desired. Likewise,in situations where the diagnosis process 800 determines that the userhas sufficiently performed the recommended remedial action(s), thediagnosis process 800 may automatically clear or otherwise remove thenotification(s) indicating the recommended remedial action(s) andprovide another notification that indicates the viability of theoperating mode (task 820). In this regard, the diagnostics module 612may detect or otherwise identify when the user has initiated a remedialaction, and in response, repeat the corresponding diagnostic check(s) toensure that the remedial action has resolved any viability concerns. Forexample, if the diagnostics module 612 may detect or otherwise verifythat the energy source 503 is sufficiently charged, the reservoircontains a sufficient amount of insulin, the sensing arrangement 504 issufficiently charged and/or calibrated, and/or the like beforeautomatically clearing the recommendations and providing indication thatentering the operating mode is now viable. Similarly, the diagnosticsmodule 612 may periodically analyze the historical delivery data, bloodglucose measurement data, sensor calibration data, and the likemaintained in memory 606 and detect or otherwise verify that all of thecontrol parameters can be determined before automatically providingindication that the operating mode is now viable.

It should be noted that in some embodiments, after the next instance ofthe destination operating mode is initiated, the diagnostics module 612may periodically perform the physical and algorithmic diagnostic checkswhile the operating mode is being implemented to verify the continuedviability of the operating mode (e.g., tasks 810, 812, 814). In suchembodiments, when the diagnostics module 612 determines that theoperating mode may not be viable, the diagnostics module 612 maygenerate or otherwise provide the appropriate recommendations to theuser (e.g., task 816) so that the user may improve the future viabilityof the operating mode before any critical alerts are generated or beforethe operating mode must be terminated. Additionally, it should be notedthat the operational information for the next instance of thedestination operating mode may be stored or otherwise maintained for usein determining an updated expected start time and an updated expectedduration during the next iteration of the diagnosis process 800 for thenext subsequent instance of the operating mode (e.g., tasks 802, 804).In this regard, the expected start time, the expected duration and/orthe buffer time may vary dynamically during operation of the infusiondevice 502 to adapt to changes in the user's usage of the particularoperating mode.

In one exemplary embodiment, the diagnosis process 800 is performed fora closed-loop operating mode that the user operates the infusion device502 in overnight while he or she is sleeping. For example, at bedtime,the user may manipulate the user interface 540, 608 to initiate theclosed-loop operating mode to regulate the user's blood glucose whilethe user is sleeping. In this regard, the infusion device 502 may storeor otherwise maintain historical operational information for theovernight closed-loop operating mode, such as, for example, therespective starting times at which the closed-loop operating mode isinitiated along with the respective durations or times at which theclosed-loop operating mode is terminated (e.g., when the user wakes upin the morning or the operating mode times out). Accordingly, during theday prior to a subsequent instance of the closed-loop operating mode,the diagnostics module 612 and/or the diagnosis process 800 maycalculate or otherwise determine the user's average bedtime (e.g., byaveraging the respective start times of the recent instances of theoperating mode) and the average duration of the operating mode (e.g.,the average amount of time the user sleeps) (e.g., tasks 802, 804).Thereafter, the diagnostics module 612 and/or the diagnosis process 800automatically performs the diagnostics checks the buffer time before theuser's average bedtime (e.g., tasks 808, 810, 812) to ensure that theovernight closed-loop operating mode will be available at the time theuser is likely to go to bed. For example, if the average bedtime for theuser is at 10 P.M. and the buffer time is determined to be five hours,the diagnostics module 612 and/or the diagnosis process 800automatically performs the diagnostics checks at 5 P.M. to providenotifications of recommended actions for the user to increase theviability or availability of the overnight closed-loop operating mode(e.g., obtain a new blood glucose reference measurement value, replaceor recalibrate the sensing arrangement 504, and the like).

Turning now to FIG. 9, in accordance with one or more embodiments, amanagement system 900 manages transitions between operating modessupported by an infusion device. In one or more exemplary embodimentsdescribed herein, the management system 900 is implemented by a pumpcontrol system 520, 600 and/or pump control module 602. In this regard,the various modules 902, 904, 906, 908, 910 may be subcomponents of thepump control module 602 or the command generation module 614. Forexample, in one embodiment, the command generation module 614 includesor otherwise implements the management system 900. The illustratedsystem 900 includes a plurality of operating mode control modules 902,904, 906, 908 along with a supervisory control module 910 that managestransitions between the respective operating modes. In the illustratedembodiment, the supervisory control module 910 operates a commandmultiplexer 920, which is coupled to the motor control module 512 tooutput a dosage command from the selected operating mode control module902, 904, 906, 908 corresponding to the operating mode currently beingimplemented by the infusion device 502.

The closed-loop control module 902 generally represents the componentsof the pump control system 520, 600 that are configured to support theclosed-loop operating mode. In this regard, the closed-loop controlmodule 902 may implement the closed-loop control system 700 of FIG. 7and generate a dosage command based on a difference between the current(or most recent) measurement of the user's interstitial fluid glucoselevel and a target (or reference) interstitial fluid glucose value.

The predictive low glucose control module 904 generally represents thecomponents of the pump control system 520, 600 that are configured tosupport a PLGM operating mode. As described above, the PLGM controlmodule 904 generates dosage commands to provide a basal infusion ratewhen a predicted glucose value is greater than a predictive suspendthreshold and automatically suspends delivery (or generates dosagecommands equal to zero) when the predicted glucose value is less thanthe predictive suspend threshold.

The low glucose control module 906 generally represents the componentsof the pump control system 520, 600 that are configured to support a LGSoperating mode. As described above, the LGS control module 906 bygenerates dosage commands to provide a basal infusion rate when thecurrent (or most recent) measurement of the user's interstitial fluidglucose level is greater than a suspend threshold and automaticallysuspends delivery when the current measurement value is less than thesuspend threshold.

The open-loop control module 908 generally represents the components ofthe pump control system 520, 600 that are configured to support anopen-loop operating mode. In this regard, the open-loop control module908 generates dosage commands configured to provide a predeterminedopen-loop basal infusion rate.

In the illustrated embodiment, the command multiplexer 920 is coupled tothe outputs of the respective control modules 902, 904, 906, 908 toselectively output the dosage command from one of the modules 902, 904,906, 908 to the motor control module 512 in response to a selectionsignal from the supervisory control module 910. In this regard, theselection signal identifies the operating mode that is currently beingimplemented by the infusion device 102, 200, 502. The supervisorycontrol module 910 generally represents the components of the pumpcontrol system 520, 600 that are coupled to the control modules 902,904, 906, 908 and configured to support the operating mode transitionprocess 1000 and perform the tasks, operations, functions, and processesdescribed herein managing transitions between operating modes associatedwith the respective control modules 902, 904, 906, 908.

It should be appreciated that FIG. 9 is a simplified representation ofthe management system 900 for purposes of explanation and is notintended to limit the subject matter described herein in any way. Inthis regard, depending on the embodiment, any number of operating modecontrol modules may be present to support any number of operating modes.In some embodiments, the features and/or functionality of the commandmultiplexer 920 may be implemented by or otherwise integrated into thesupervisory control module 910. Furthermore, while in some embodimentsthe features and/or functionality of the management system 900 areimplemented by control electronics 224 located in the fluid infusiondevice 200, 502, in alternative embodiments, various aspects of themanagement system 900 may be implemented by a remote computing devicethat is physically distinct and/or separate from the infusion device200, 502, such as, for example, the CCD 106 or the computing device 108.

FIG. 10 depicts an exemplary operating mode transition process 1000suitable for implementation by a control system associated with a fluidinfusion device to manage transitions between operating modes supportedby the device. Various tasks performed in connection with the operatingmode transition process 1000 may be performed by hardware, firmware,software executed by processing circuitry, or any combination thereof.For illustrative purposes, the following description refers to elementsmentioned above in connection with FIGS. 1-7. In practice, portions ofthe operating mode transition process 1000 may be performed by differentelements of the control system 500, such as, for example, the infusiondevice 502, the pump control system 520, 600, the diagnostics module612, the command generation module 614, the management system 900, thesupervisory control module 910 and/or the command multiplexer 920. Itshould be appreciated that the operating mode transition process 1000may include any number of additional or alternative tasks, the tasksneed not be performed in the illustrated order and/or the tasks may beperformed concurrently, and/or the operating mode transition process1000 may be incorporated into a more comprehensive procedure or processhaving additional functionality not described in detail herein.Moreover, one or more of the tasks shown and described in the context ofFIG. 10 could be omitted from a practical embodiment of the operatingmode transition process 1000 as long as the intended overallfunctionality remains intact.

Referring to FIG. 10, and with continued reference to FIG. 9, theoperating mode transition process 1000 initializes or otherwise beginsin response to detecting or otherwise identifying a desire to exit aparticular operating mode. For example, the operating mode transitionprocess 1000 may be initiated in response to a user manipulating theuser interface 540, 608 to indicate a desire to exit one operating modeand enter another operating mode. In other embodiments, the operatingmode transition process 1000 may be initiated in response to aparticular operating mode automatically determining it should be exitedand providing a corresponding indication to the supervisory module 910.For example, a maximum time limit may be imposed for one or more of thecontrol modules 902, 904, 906, 908, with the respective control module902, 904, 906, 908 implementing a timer and automatically notifying thesupervisory control module 910 when the maximum time limit has beenreached. Alternatively, the supervisory control module 910 may implementthe appropriate timers and identify when the maximum time limit for aparticular operating mode has been reached. Additionally, in someembodiments, one or more of the control modules 902, 904, 906, 908 maybe configured to continually monitor or analyze its performance anddetect or otherwise identify that its operating mode should beterminated when its performance appears to be unreliable. For example,the closed-loop control module 902 may automatically identify that theclosed-loop operating mode should exit when one or more of theclosed-loop control parameters appears to be invalid or unreliable, whenmeasurement values from the sensing arrangement 504 appear to be invalidor unreliable, or the like.

In response to detecting or otherwise identifying a desire to exit aparticular operating mode, the operating mode transition process 1000receives or otherwise obtains operational information pertaining to theoperating mode being exited along with clinical information pertainingto the physiological condition of the user (tasks 1002, 1004). In thisregard, the supervisory module 910 obtains operational information fromthe control module 902, 904, 906, 908 associated with the operating modecurrently being implemented. The operational information includes timervalues (e.g., a delivery suspend time, a refractory period time, and thelike), delivery status (e.g., whether or not delivery has beensuspended), alert or event information (e.g., hypoglycemic events oralerts, hyperglycemic events or alerts, and the like), the reason theoperating mode is terminating (e.g., manually-initiated, timeout,invalid control parameters and/or invalid measurement values, ananomalous condition, or the like), and other information characterizingthe current instance of the operating mode. In exemplary embodiments,the supervisory module 910 obtains clinical information for the user,such as, for example, recent sensor glucose measurement values,predicted glucose measurement values, blood glucose referencemeasurement values, sensor calibration data, other historical data, andthe like, from memory 606.

Using the operational information and the clinical information, the modetransition process 1000 identifies or otherwise determines the availableoperating modes for the transition destination (task 1006). In thisregard, the supervisory module 910 utilizes the clinical information inconjunction with the operational information to identify which otheroperating modes are viable destinations for the transition whileexcluding any operating modes that are likely to violate one or moreapplicable constraints or otherwise are not likely to be viable. In thismanner, the mode transition process 1000 increases the likelihood thatthe destination operating mode will not result in violations ofapplicable delivery control rules, constraints, limits, or the like. Themode transition process 1000 also reduces the likelihood that thedestination operating mode will generate alerts that could degrade theuser experience, and reduces the likelihood that the destinationoperating mode will automatically terminate or exit after beingactivated.

For example, in one or more embodiments, a maximum suspension time limitmay be imposed on the infusion device 502 across all operating modes,with the supervisory module 910 excluding operating modes that wouldlikely result in the minimum suspension time being violated based on thecurrent suspend duration for the initial operating mode and the currentor predicted glucose values for the user. For example, if transitioningfrom a closed-loop operating mode that has been suspending delivery fora period of time, and the user's predicted glucose value indicates thePLGM operating mode will likely suspend delivery for an additionalamount of time such that the sum of the current suspend duration for theclosed-loop operating mode and the expected suspend duration for thePLGM operating mode exceeds the maximum suspension time, the supervisorymodule 910 may exclude the PLGM operating mode from consideration as apossible destination operating mode.

As another example, a maximum insulin delivery limit over a particulartimeframe (e.g., the preceding 24 hours) may be imposed, with thesupervisory module 910 excluding operating modes that would likelyresult in the maximum insulin delivery limit being delivered based onthe amount of insulin delivered for the initial operating mode and thecurrent or predicted glucose values for the user. For example, if thedifference between current and/or predicted glucose values for the userand the target glucose value for the closed-loop operating modeindicates that the closed-loop operating mode is likely to result in anamount of fluid delivery that would cause a maximum insulin deliverylimit to be violated, the supervisory module 910 may exclude theclosed-loop operating mode from consideration as a possible destinationoperating mode. In lieu of the closed-loop operating mode, in someembodiments, if the mode transition process 1000 is initiated inresponse to the maximum insulin delivery limit being reached duringimplementation of a current operating mode, a safe basal delivery mode(or hybrid closed-loop delivery mode) may be identified as a possibledestination operating mode. The safe basal delivery mode may be realizedas a hybrid closed-loop operating mode that configured to maintain adelivery rate that does not violate either the maximum insulin deliverylimit or a minimum insulin delivery limit independent of the current orpredicted measurements of the user's glucose. In this regard, the safebasal delivery mode may impose a maximum delivery rate that is less thanor equal to the maximum insulin delivery limit divided by its applicabletimeframe and impose a minimum delivery rate that is greater than theminimum insulin delivery limit divided by its applicable timeframe.Thus, the delivery commands generated in the safe basal delivery modebased on the difference between the current sensor glucose measurementvalue and the target glucose measurement value are bounded such thatthey will not violate applicable delivery limits.

Similarly, the supervisory module 910 may exclude operating modes thatwould likely result in the minimum insulin delivery limit being violatedbased on the amount of insulin delivered for the initial operating modeand the current or predicted glucose values for the user. For example,if the difference between current and/or predicted glucose values forthe user and the target glucose value indicates the closed-loopoperating mode is unlikely to deliver fluid for an amount of time thatwould cause the minimum insulin delivery limit to be violated, thesupervisory module 910 may exclude the closed-loop operating mode fromconsideration as a possible destination operating mode. In someembodiments, if the mode transition process 1000 is initiated inresponse to the minimum insulin delivery limit being reached duringimplementation of a current operating mode, a safe basal delivery modemay be identified as a possible destination operating mode in lieu ofthe closed-loop operating mode.

As another example, the supervisory module 910 may exclude operatingmodes that utilize sensor glucose measurement values based on sensorhealth information. In this regard, recent sensor glucose measurementvalues or historical calibration information for the sensing arrangement504 indicating that the sensing arrangement 504 may not be viable forthe particular operating mode. In this regard, if the previous sensorglucose measurement values or historical calibration informationindicates the sensing arrangement 504 is unhealthy or may requirerecalibration or replacement, the supervisory module 910 prevents entryof operating modes that would otherwise be relying potentiallyunreliable sensor measurement values. For example, the supervisorymodule 910 may exclude the closed-loop operating mode from considerationas a possible destination operating mode if a difference between thecurrent sensor glucose measurement value and a predicted glucose valueis greater than a threshold value, a calibration factor for the sensingarrangement 504 has expired, communications with the sensing arrangement504 have been interrupted, a difference between the current calibrationfactor and the preceding calibration factor is greater than a thresholdamount (e.g., a difference of more than 35%), or a difference betweenreference blood glucose measurement value and the corresponding sensormeasurement value used for the current calibration factor is greaterthan a threshold amount (e.g., the sensor measurement value is more than35% greater than or less than the reference blood glucose measurementvalue). In other embodiments, an operating mode that utilizes sensorglucose measurement values may be excluded when a duration of time thathas elapsed since the most recent calibration exceeds a threshold value.

In one exemplary embodiment, a desired maximum number of alerts over aparticular timeframe (e.g., the preceding 24 hours) could be designatedby the user, with the supervisory module 910 excluding operating modesthat would likely result in that maximum number of alerts beingexceeded. For example, the operational information obtained by thesupervisory module 910 may include a current number of usernotifications or alerts that have been generated by the currentoperating mode (e.g., by the respective control module 902, 904, 906,908 implementing a corresponding counter). The supervisory module 910may determine an expected number of user notifications or alerts to begenerated by a particular operating mode based on the current and/orpredicted glucose values for the user, and exclude that operating modefrom the set of possible destination operating modes when the sum of theexpected number of alerts and the current number of alerts exceeds themaximum number chosen by the user.

In one or more embodiments, the supervisory module 910 excludesoperating modes based on the status of user notifications previouslygenerated by the infusion device 502. For example, if a usernotification has been generated that indicates the user shouldrecalibrate or replace the sensing arrangement 504, and the user has notresponded to the user notification by recalibrating or replacing thesensing arrangement 504 within a threshold amount of time (e.g., 90minutes), the supervisory module 910 may exclude the closed-loopoperating mode or other operating modes that rely on the sensingarrangement 504 from consideration as possible destination modes untilthe user responds to the notification.

Additionally, in one or more embodiments, the supervisory module 910performs one or more diagnostic checks for the potential destinationoperating modes to verify or otherwise confirm the potential destinationoperating modes will be viable, in a similar manner as described abovein the context of FIG. 8 (e.g., tasks 810, 812, 814). In this regard, ifthe operational information and/or the clinical information indicatesthat an operating mode is unlikely to be viable for the entirety of itsexpected or foreseeable duration, the supervisory module 910 may excludethat operating mode from consideration. For example, the supervisorymodule 910 may verify or otherwise determine that the control parametersof the closed-loop operating mode can be calculated and will be validfor the expected duration before including the closed-loop operatingmode in the group of potential destination operating modes. In thisregard, if transitioning to the closed-loop operating mode may requireaffirmative user action (e.g., the user manipulating the blood glucosemeter 530 to obtain one or more blood glucose measurement values), thesupervisory module 910 may exclude the closed-loop operating mode fromthe potential destination operating modes. In some embodiments, thesupervisory module 910 may also generate or otherwise provide one ormore user notifications of recommended remedial actions to improve thefuture viability of an excluded operating mode in a similar manner asdescribed above (e.g., task 816).

Still referring to FIG. 10, after identifying the available operatingmodes for a potential transition destination, the mode transitionprocess 1000 continues by identifying or otherwise selecting adestination operating mode from among the group of available operatingmodes (task 1008). In exemplary embodiments, the supervisory module 910automatically selects the available operating mode to that is mostpreferable or most highly ranked based on device settings or userpreferences maintained in memory 606. In this regard, the user maymanipulate a user interface 540, 608 to establish a hierarchicalordering of the operating modes in the user's order of preference, withthe hierarchical information being stored in the memory 606 along withother user preferences. For example, the user may identify theclosed-loop operating mode as the most preferred operating mode,followed by the PLGM operating mode as the next most preferred operatingmode, the LGS operating mode as the next most preferred operating mode,and the open-loop operating mode as the least preferred operating mode.In other embodiments, default settings for the infusion device 102, 200,502 may specify a default hierarchical order of operating modes. Itshould be appreciated, however, that the subject matter described hereinis not limited to any particular type of selection criteria used toidentify the most preferable operating mode from among the availableoperating modes.

After selecting the destination operating mode, the mode transitionprocess 1000 continues by identifying or otherwise determining the typesor subset of operational information pertaining to the current operatingmode to be provided to the destination operating mode and providing thatidentified operational information to the destination operating mode(tasks 1010, 1012). In this regard, the supervisory module 910 passes atleast a portion of the operational information obtained from the currentoperating mode control module 902, 904, 906, 908 to the destinationmodule 902, 904, 906, 908 such that the implementation of thedestination operating mode does not violate any delivery rules,constraints, limits, or the like. For example, the supervisory module910 may obtain the current refractory period timer value, the currentsuspend duration timer value, or the like, from the control module 902,904, 906, 908 corresponding to the current operating mode and providethose values to the control module 902, 904, 906, 908 corresponding tothe destination operating mode to ensure that the destination operatingmode does not violate a minimum refractory time period betweensuspending delivery, a maximum suspend duration, a minimum suspendduration, or the like. Additionally, the supervisory module 910 mayprovide the exit reason for the current operating mode, the currentdelivery status, information about alerts or events that occurred duringthe current operating mode, active insulin estimates, sensor healthstatus and/or calibration information, and/or other historical deliveryinformation to the destination operating mode control module 902, 904,906, 908. The destination operating mode generates dosage commands inaccordance with the operational information received from the precedingoperating mode to provide a relatively seamless transition amongoperating modes.

Referring again to FIG. 10, the mode transition process 1000 continuesby providing, to the infusion device motor control module, the dosage(or delivery) commands generated by the destination operating mode inaccordance with the provided operational information (task 1014). Inthis regard, the supervisory module 910 signals, commands or otherwiseoperates the command multiplexer 920 to output dosage commands generatedby the destination operating mode control module 902, 904, 906, 908 andcease outputting dosage commands from the previously-active operatingmode. For example, to transition from the closed-loop operating mode tothe PLGM operating mode, the supervisory module 910 signals, commands orotherwise operates the command multiplexer 920 to output dosage commandsgenerated by the PLGM control module 904 instead of the closed-loopcontrol module 902. Additionally, in some embodiments, the supervisorymodule 910 may assert or otherwise provide interrupt signals thatindicate, to the respective control modules 902, 904, 906, 908, whetheror not the respective control module 902, 904, 906, 908 should generatedosage commands. For example, the supervisory module 910 may deactivatethe closed-loop control module 902 (e.g., by providing a logical highinterrupt signal to the closed-loop control module 902) and activate thePLGM control module 904 (e.g., by providing a logical low interruptsignal to the PLGM control module 904) while maintaining the othercontrol modules 906, 908 deactivated.

Referring to FIG. 9, in accordance with one embodiment, whentransitioning from the closed-loop operating mode to the PLGM operatingmode, the supervisory module 910 obtains information identifying theexit reason (e.g., manual or auto), the amount of time delivery has beensuspended in the preceding sixty minutes, and the current value of theclosed-loop refractory timer from the closed-loop control module 902. Insome embodiments, the supervisory module 910 calculates the refractorytime based on the amount of continuous delivery commands that precedethe transition. The supervisory module 910 provides the obtained valuesand information to the PLGM control module 904, and thereafter, the PLGMcontrol module 904 generates dosage commands in accordance with theoperational information from the closed-loop control module 902.

For example, the PLGM control module 904 may set its refractory timer tothe value of the closed-loop refractory timer and maintain deliveryuntil the total refractory time exceeds the minimum refractory timeperiod before suspending delivery. Thus, even if the user's predictedglucose level is below the predictive suspend threshold, the PLGMcontrol module 904 may continue providing dosage commands that result ina basal rate of infusion until the value of the PLGM refractory timer isgreater than or equal to the minimum refractory time period. In someembodiments, the PLGM control module 904 may utilize the exit reason todetermine whether to continue providing dosage commands until the valueof the PLGM refractory timer is greater than or equal to the minimumrefractory time period. For example, if the exit reason is manual (e.g.,the user manually transitioned the infusion device 502 to the PLGMmode), the PLGM control module 904 may provide dosage commands until theminimum refractory time period is observed, however, if the exit reasonis automatic, the PLGM control module 904 may suspend dosage commandsbefore the minimum refractory time period is observed and reset the PLGMrefractory timer as appropriate.

In some embodiments, the sensor health status and/or calibrationinformation, estimated active insulin information, and/or otheroperational information from the closed-loop operating mode may beutilized in conjunction with the exit reason when determining whether toobserve the minimum refractory time period in the PLGM operating mode.For example, the PLGM control module 904 may allow dosage commands to besuspended only if the sensing arrangement 504 was calibrated less than athreshold amount of time before the transition (e.g., within the lasthour) and the estimated active insulin is greater than a safe thresholdvalue, which may be manually set by a user or a default value maintainedby the infusion device 502. Thus, the minimum refractory time period maystill be observed for an automatic transition if the sensing arrangement504 was not calibrated recently or the estimated active insulin is toolow. Conversely, the PLGM control module 904 may automatically suspenddelivery when the refractory time from the closed-loop control module902 is less than the minimum refractory time period in response todetermining the active insulin estimate from the closed-loop controlmodule 902 is greater than the threshold value.

Similarly, if delivery is currently being suspended, the PLGM controlmodule 904 may set its delivery suspend timer to the value of theclosed-loop suspend timer (e.g., the amount of time delivery has beensuspended in the preceding sixty minutes). Thus, even if the user'spredicted glucose level is below the predictive suspend threshold, thePLGM control module 904 may begin providing dosage commands once thevalue of the PLGM delivery suspend timer is greater than the maximumsuspension time period. Additionally, in some embodiments, the exitreason may be utilized by the PLGM control module 904 to determinewhether to suspend delivery or resume delivery, either independently orin conjunction with the sensor health status and/or calibrationinformation, estimated active insulin information, and/or otheroperational information, in a similar manner as described above. Forexample, if the sensing arrangement 504 was calibrated less than athreshold amount of time before the transition (e.g., within the lasthour) and the estimated active insulin is less than a threshold value,the PLGM control module 904 may resume providing dosage commands eventhough the maximum suspension time period may not have been met.

When transitioning from the closed-loop operating mode to the LGSoperating mode, the supervisory module 910 obtains informationidentifying the exit reason (e.g., manual or auto), the amount of timedelivery has been suspended in the preceding sixty minutes, and thecurrent value of the closed-loop refractory timer from the closed-loopcontrol module 902 and provides the obtained values and information tothe LGS control module 906 for generating dosage commands in accordancetherewith, in a similar manner as described above for transitions to thePLGM operating mode.

In another example embodiment, when transitioning from the closed-loopoperating mode to the open-loop operating mode, the supervisory module910 may only provide the refractory timer values from the closed-loopcontrol module 902 to the open-loop control module 908. In such anembodiment, the open-loop control module 908 provides dosage commandsthat result in an open-loop basal rate of infusion while dynamicallyupdating the refractory timer value for a subsequent transition toanother operating mode. In this regard, the refractory timer value isupdated so that if the infusion device 502 subsequently transitions fromthe open-loop operating mode to another operating mode where deliverycould be suspended, the minimum refractory period is still observed bythe control module 902, 904, 906 associated with that subsequentoperating mode before delivery is suspended. In other embodiments, inlieu of providing the refractory time information to the open-loopcontrol module 908, the supervisory module 910 may independently manageand dynamically update the refractory time information, and subsequentlyprovide the refractory time information to another destination controlmodule 902, 904, 906 when transitioning from the open-loop operatingmode. Similarly, in some embodiments, the supervisory module 910 mayprovide suspension information to the open-loop control module 908(e.g., the amount of time delivery was suspended over a preceding timeinterval) for dynamically updating the suspension time information toensure any maximum suspension limits are still observed by a controlmodule 902, 904, 906 associated with that subsequent operating mode.Alternatively, the supervisory module 910 may also independently manageand dynamically update the refractory time information, and subsequentlyprovide the refractory time information to a destination control module902, 904, 906 when transitioning from the open-loop operating mode.

In other exemplary embodiments, when transitioning from the PLGMoperating mode or the LGS operating mode to the closed-loop operatingmode, the supervisory module 910 obtains information identifying theexit reason (e.g., manual or auto) and the current value of therespective refractory timer from the respective control module 904, 906and provides the obtained values and information to the closed-loopcontrol module 902. In this regard, the closed-loop control module 902sets its refractory timer to the value of the refractory timer of therespective control module 904, 906 and may maintain delivery until thetotal refractory time exceeds the minimum refractory time period beforesuspending delivery. In other embodiments, the closed-loop controlmodule 902 may suspend delivery even though the total refractory time isless than the minimum refractory time period. For example, theclosed-loop control module 902 may obtain sensor calibration informationfrom the preceding operating mode and determine whether a duration oftime that has elapsed since the most recent calibration exceeds athreshold value corresponding to the reliable lifetime of a calibrationfactor for purposes of the closed-loop mode. When the duration of timethat has elapsed since the most recent calibration exceeds the thresholdvalue, the closed-loop control module 902 may generate a notificationvia the user interface 540 that prompts the user to obtain a new bloodglucose reference measurement value for recalibrating the sensingarrangement 504 upon transitioning to the closed-loop mode. In responseto the user manipulating the blood glucose meter 530 to obtain a newblood glucose reference measurement value, and the new blood glucosereference measurement value indicates delivery should be suspended, theclosed-loop control module 902 may suspend delivery even though thetotal refractory time does not exceed the minimum refractory timeperiod. Alternatively, in the absence of a new blood glucose referencemeasurement value that indicates delivery should be suspended, theclosed-loop control module 902 may generate dosage commands to provide aminimum basal rate of infusion while the closed-loop refractory timervalue is less than the minimum refractory time period even though theuser's current glucoses measurement value may be less than the targetglucose value for the closed-loop control system.

In yet other exemplary embodiments, when transitioning from theopen-loop operating mode to another operating mode, the supervisorymodule 910 obtains information identifying the exit reason (e.g., manualor auto) and the current value of the refractory timer from theopen-loop module 908 and provides the obtained value to the particulardestination operating mode control module 902, 904, 906. In this regard,when transitioning from the open-loop operating mode, the destinationoperating mode control module 902, 904, 906 sets its refractory timer tothe value provided by the supervisory module 910 to maintain deliveryuntil the total refractory time exceeds the minimum refractory timeperiod before allowing delivery to be suspended.

It will be appreciated that in practice there are numerous differenttypes of information that may be exchanged among control modules 902,904, 906, 908 to achieve a desired manner of transitioning and complywith the particular constraints, rules, and/or limits for a particularapplication. Accordingly, the above examples are provided merely to aidin understanding of the subject matter and are not intended to belimiting.

It should also be noted that in practice, the diagnosis process 800 ofFIG. 8 and the mode transition process 1000 of FIG. 10 may beimplemented independently, or alternatively, in conjunction with oneanother. In this regard, the diagnosis process 800 may be performed toincrease the likelihood of availability of the various operating modeswhen the mode transition process 1000 is performed at the expected starttime, thereby increasing the likelihood of the supervisory module 910identifying more than one potential destination operating mode (e.g.,task 1006) when the mode transition process 1000 is performed. Byincreasing the availability of the various operating modes, a desiredlevel of control of the user's physiological condition can be morereadily achieved in a manner that minimizes undesirable disruptionsduring implementation of the desired operating mode, thereby improvingthe user experience.

To briefly summarize, the subject matter described herein facilitatestransitioning between operating modes in a manner that enhances the userexperience (e.g., by enabling the user to proactively increase viabilityof a desired operating mode and/or excluding operating modes that arelikely to generate alerts from possible destinations for automatictransitions) and ensures compliance with applicable delivery controlrules and other constraints (e.g., by excluding operating modes that areotherwise likely to result in a violation and transferring timer and/orcounter values across operating modes).

For the sake of brevity, conventional techniques related to glucosesensing and/or monitoring, closed-loop glucose control, predictiveglucose management, sensor calibration and/or compensation, and otherfunctional aspects of the subject matter may not be described in detailherein. In addition, certain terminology may also be used in the hereinfor the purpose of reference only, and thus is not intended to belimiting. For example, terms such as “first”, “second”, and other suchnumerical terms referring to structures do not imply a sequence or orderunless clearly indicated by the context. The foregoing description mayalso refer to elements or nodes or features being “connected” or“coupled” together. As used herein, unless expressly stated otherwise,“coupled” means that one element/node/feature is directly or indirectlyjoined to (or directly or indirectly communicates with) anotherelement/node/feature, and not necessarily mechanically.

While at least one exemplary embodiment has been presented in theforegoing detailed description, it should be appreciated that a vastnumber of variations exist. It should also be appreciated that theexemplary embodiment or embodiments described herein are not intended tolimit the scope, applicability, or configuration of the claimed subjectmatter in any way. For example, the subject matter described herein isnot limited to the infusion devices and related systems describedherein. Moreover, the foregoing detailed description will provide thoseskilled in the art with a convenient road map for implementing thedescribed embodiment or embodiments. It should be understood thatvarious changes can be made in the function and arrangement of elementswithout departing from the scope defined by the claims, which includesknown equivalents and foreseeable equivalents at the time of filing thispatent application. Accordingly, details of the exemplary embodiments orother limitations described above should not be read into the claimsabsent a clear intention to the contrary.

What is claimed is:
 1. A method of operating an infusion device operable to deliver fluid to a user, the method comprising: operating the infusion device to deliver the fluid in an automated manner in accordance with a first operating mode of a plurality of different operating modes, each operating mode of the plurality of different operating modes generating commands for delivering the fluid to the user in an automated manner in accordance with a different delivery control scheme associated therewith; obtaining operational information pertaining to the operating of the infusion device in accordance with the first operating mode; obtaining clinical information pertaining to the user; determining a destination operating mode of the plurality of different operating modes based at least in part on the operational information and the clinical information; transitioning operation of the infusion device from the first operating mode to the destination operating mode, wherein the destination operating mode is initialized using at least a portion of the operational information pertaining to the operating of the infusion device in accordance with the first operating mode; and operating the infusion device to deliver the fluid in accordance with the destination operating mode in a manner that is influenced by the portion of the operational information pertaining to the first operating mode.
 2. The method of claim 1, wherein: the first operating mode comprises one of a closed-loop operating mode, a predictive low glucose management operating mode, and a low glucose suspend operating mode; and the destination operating mode comprises a different one of the closed-loop operating mode, the predictive low glucose management operating mode, and the low glucose suspend operating mode.
 3. The method of claim 1, wherein: the first operating mode comprises an overnight closed-loop operating mode; and the destination operating mode comprises one of a predictive low glucose management operating mode, a low glucose suspend operating mode, a safe basal delivery mode, and an open-loop operating mode.
 4. The method of claim 1, the first operating mode having a first control module associated therewith and the destination operating mode having a second control module associated therewith, wherein transitioning operation of the infusion device from the first operating mode to the destination operating mode comprises a supervisory control module operating a command multiplexer to output second dosage commands generated by the second control module and cease outputting first dosage commands generated by the first control module.
 5. The method of claim 1, the first operating mode having a first control module associated therewith and the destination operating mode having a second control module associated therewith, wherein transitioning operation of the infusion device from the first operating mode to the destination operating mode comprises a supervisory control module providing the portion of the operational information from the first control module to the second control module.
 6. The method of claim 1, the portion of the operational information comprising an exit reason for the first operating mode, wherein operating the infusion device to deliver the fluid in accordance with the destination operating mode in a manner that is influenced by the portion of the operational information pertaining to the first operating mode comprises the destination operating mode determining whether to suspend or resume delivery of the fluid based at least in part on the exit reason.
 7. The method of claim 1, wherein determining the destination operating mode comprises: identifying a set of one or more possible operating modes of the plurality of different operating modes by excluding an operating mode of the plurality of different operating modes when the clinical information indicates the operating mode will violate a delivery control rule based on the operational information; and selecting the destination operating mode from the set.
 8. The method of claim 7, the clinical information including a current glucose measurement value and the operational information including a suspended delivery time for the first operating mode, wherein excluding the operating mode comprises excluding the operating mode when the current glucose measurement value indicates the operating mode will violate a suspension time limit based on the suspended delivery time.
 9. The method of claim 7, the clinical information including a current glucose measurement value and an insulin delivered, wherein excluding the operating mode comprises excluding the operating mode when the current glucose measurement value indicates the operating mode will violate an insulin delivery limit.
 10. The method of claim 1, wherein determining the destination operating mode comprises: identifying a set of one or more possible operating modes of the plurality of different operating modes by excluding an operating mode of the plurality of different operating modes when the clinical information indicates the operating mode will generate a user notification; and selecting the destination operating mode from the set.
 11. The method of claim 1, wherein: the operational information includes a first number of user notifications generated by the first operating mode; and determining the destination operating mode comprises: determining an operating mode of the plurality of different operating modes is likely to generate a second number of user notifications based on the clinical information; identifying a set of one or more possible operating modes of the plurality of different operating modes by excluding the operating mode of the plurality of different operating modes from the set when a sum of the first number and the second number is greater than a threshold number of user notifications; and selecting the destination operating mode from the set.
 12. The method of claim 1, wherein determining the destination operating mode comprises: identifying a set of one or more possible operating modes of the plurality of different operating modes by excluding an operating mode of the plurality of different operating modes when the clinical information indicates the operating mode will automatically terminate; and selecting the destination operating mode from the set.
 13. The method of claim 1, wherein determining the destination operating mode comprises: identifying a set of one or more possible operating modes of the plurality of different operating modes by excluding an operating mode of the plurality of different operating modes in response to determining the operating mode is not viable for an expected duration based at least in part on the clinical information; and selecting the destination operating mode from the set.
 14. The method of claim 1, wherein: the portion of the operational information includes sensor health information; and determining the destination operating mode comprises: identifying a set of one or more possible operating modes of the plurality of different operating modes by excluding an operating mode of the plurality of different operating modes based on the sensor health information; and selecting the destination operating mode from the set.
 15. The method of claim 14, wherein excluding the operating mode comprises excluding the operating mode that utilizes sensor glucose measurement values when at least one of: a first difference between a current sensor glucose measurement value and a predicted glucose value is greater than a first threshold; a calibration factor for a sensing arrangement has expired; communications with the sensing arrangement have been interrupted; a second difference between a current calibration factor and a preceding calibration factor is greater than a second threshold; a third difference between a reference blood glucose measurement value and a corresponding sensor measurement value used for the current calibration factor is greater than a third threshold; or a duration of time that has elapsed since a most recent calibration exceeds a fourth threshold.
 16. The method of claim 1, wherein determining the destination operating mode comprises: identifying a set of one or more possible operating modes of the plurality of different operating modes; and selecting a highest ranked operating mode from a hierarchical ordering of the set as the destination operating mode.
 17. The method of claim 16, further comprising determining the hierarchical ordering of the one or more possible operating modes of the set based on user preferences.
 18. An infusion device comprising: a data storage element to maintain operational information pertaining to a first operating mode of a plurality of different operating modes and clinical information pertaining to a user; a motor operable to deliver fluid to a body of the user, the fluid influencing a physiological condition of the user; and a control system coupled to the motor and the data storage element to: operate the motor to deliver the fluid in an automated manner in accordance with the first operating mode; determine a destination operating mode of the plurality of different operating modes based at least in part on the operational information and the clinical information; and transition from the first operating mode to the destination operating mode to operate the motor to deliver the fluid in an automated manner in accordance with the destination operating mode, wherein: the destination operating mode is initialized using at least a portion of the operational information pertaining to the first operating mode; and each different operating mode of the plurality of different operating modes generates commands for delivering the fluid to the user in an automated manner in accordance with a different delivery control scheme.
 19. The infusion device of claim 18, further comprising: a first control module associated with the first operating mode; and a second control module associated with the destination operating mode, wherein the control system transitions from the first operating mode to the destination operating mode by providing the portion of the operational information pertaining to the first operating mode to the second control module.
 20. The infusion device of claim 18, further comprising: a first control module associated with the first operating mode; a second control module associated with the destination operating mode; and a command multiplexer coupled to the first control module and the second control module, wherein the control system is coupled to the command multiplexer and transitions from the first operating mode to the destination operating mode by operating the command multiplexer to output second dosage commands generated by the second control module and cease outputting first dosage commands generated by the first control module. 